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Simon Heller - One of the best experts on this subject based on the ideXlab platform.

  • 1004-P: Oral Semaglutide vs. Placebo in Patients with Type 2 Diabetes and Moderate Renal Impairment: PIONEER 5
    Diabetes, 2019
    Co-Authors: Ofri Mosenzon, Simon Heller, Richard E. Pratley, Signe Rosenlund, Jan W. Eriksson, Thozhukat Sathyapalan, Thalia Marie Blicher, Ole H. Hels, Cyrus Desouza
    Abstract:

    Patients (pts) with T2D and renal impairment have limited glucose-lowering treatment options. Oral semaglutide (sema) 14 mg once daily (N=163) was compared with placebo (pbo, N=161) in a 26-week, randomized, phase 3a trial (NCT02827708) in pts with T2D and moderate renal impairment (eGFR 30-59 mL/min/1.73 m2), receiving 1-2 glucose-lowering agents (could include basal insulin). Endpoints: change in HbA1c (primary) and body weight (BW, secondary) to week 26. Two estimands were defined: treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product without rescue medication) in all randomized pts. Oral sema was superior to (treatment policy) and significantly better than (trial product) pbo in reducing HbA1c and BW (Table). More pts reached HbA1c, BW loss, and composite targets with oral sema. At follow-up, eGFR was unchanged. Fewer pts on oral sema required rescue medication (4 vs. 10%). Adverse events were more frequent with oral sema (74 vs. 65%), most often mild/moderate nausea (19 vs. 7%). More patients on oral sema prematurely discontinued trial product (15 vs. 5%), mainly due to nausea and vomiting. In conclusion, in pts with T2D and moderate renal impairment, oral sema provided superior glycemic control and BW loss compared to pbo at 26 weeks, did not appear to affect renal function, and was well tolerated in line with the population and GLP-1RA class. Disclosure O. Mosenzon: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi. Research Support; Self; AstraZeneca, Novo Nordisk Inc. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis. S. Rosenlund: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. J.W. Eriksson: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Merck Sharp & Dohme Corp., Novo Nordisk A/S. Research Support; Self; AstraZeneca, Novo Nordisk A/S. S.R. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Zealand Pharma A/S. Consultant; Self; Novo Nordisk A/S. Speaker9s Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. R.E. Pratley: Consultant; Self; Sanofi US. Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Janssen Global Services, LLC., Janssen Research & Development, Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Mundipharma, Novo Nordisk Inc., Pfizer Inc., Sanofi, Takeda Development Center Americas, Inc. T. Sathyapalan: Speaker9s Bureau; Self; Novo Nordisk Foundation. Other Relationship; Self; Bristol-Myers Squibb Company, Eli Lilly and Company, Sanofi-Aventis. T.M. Blicher: Employee; Self; Novo Nordisk A/S. O.H. Hels: Employee; Self; Novo Nordisk A/S. C. Desouza: Consultant; Self; Novo Nordisk A/S, Sanofi US. Funding Novo Nordisk A/S

  • 11-LB: Nonsevere Hypoglycemia Predicts Increased Risk of Subsequent Severe Events in Patients with Type 2 Diabetes
    Diabetes, 2019
    Co-Authors: Simon Heller, Elise Hachmann-nielsen, Kajsa Kvist
    Abstract:

    It is well-known that higher rates of non-severe hypoglycemic episodes (NSHEs) associate with a greater risk of severe hypoglycemic episodes (SHEs) in patients with type 1 diabetes. We investigated whether a similar association existed in patients with type 2 diabetes (T2D). We explored if annual rate of NSHEs was associated with time to first SHE, cardiovascular (CV) death, time to first major adverse CV event (MACE), and all cause death in patients with T2D using data from LEADER, a CV outcomes trial with 9340 patients with T2D.We used a Cox proportional hazards model adjusted for randomized treatment arm, and annual rate of NSHE as a time-dependent covariate with three levels; A: Disclosure S.R. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Zealand Pharma A/S. Consultant; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. E. Hachmann-Nielsen: Employee; Self; Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Funding Novo Nordisk

  • target fasting plasma glucose fpg without nocturnal hypoglycemia in patients with type 1 diabetes or type 2 diabetes results from switch trials
    Diabetes, 2018
    Co-Authors: Carol H. Wysham, Wendy Lane, Steen Ladelund, Deniz Tutkunkardas, Simon Heller
    Abstract:

    Insulin degludec (degludec) is a basal insulin that results in a lower FPG than insulin glargine 100 units/mL (glargine U100), which may increase the risk of nocturnal hypoglycemia in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D). This post-hoc analysis investigated the proportion of patients with T1D or T2D treated with degludec or glargine U100 meeting the ADA recommended upper limit of the pre-meal plasma glucose goal of In conclusion, compared with glargine U100, treatment with degludec was associated with greater opportunity to reach target FPG without an increased risk of nocturnal hypoglycemia. Disclosure C.H. Wysham: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi. Consultant; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Insulet Corporation, Novo Nordisk Inc., Sanofi. W. Lane: Advisory Panel; Self; Novo Nordisk A/S, Insulet Corporation, Intarcia Therapeutics, Inc., Sanofi. Research Support; Self; Novo Nordisk A/S, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Sanofi, Dexcom, Inc.. Speaker9s Bureau; Self; Novo Nordisk A/S, Insulet Corporation. S. Ladelund: Employee; Self; Novo Nordisk A/S, Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Technical University of Denmark. Research Support; Self; Metropolitan University College, Denmark. D. Tutkunkardas: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. S. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Takeda, Sanofi-Aventis, Boehringer Ingelheim GmbH. Consultant; Self; Eli Lilly and Company, Novo Nordisk A/S. Speaker9s Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Merck Sharp & Dohme Corp., Takeda, AstraZeneca, Boehringer Ingelheim GmbH.

  • Target Fasting Plasma Glucose (FPG) without Nocturnal Hypoglycemia in Patients with Type 1 Diabetes or Type 2 Diabetes—Results from SWITCH Trials
    Diabetes, 2018
    Co-Authors: Carol H. Wysham, Wendy Lane, Steen Ladelund, Deniz Tutkunkardas, Simon Heller
    Abstract:

    Insulin degludec (degludec) is a basal insulin that results in a lower FPG than insulin glargine 100 units/mL (glargine U100), which may increase the risk of nocturnal hypoglycemia in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D). This post-hoc analysis investigated the proportion of patients with T1D or T2D treated with degludec or glargine U100 meeting the ADA recommended upper limit of the pre-meal plasma glucose goal of In conclusion, compared with glargine U100, treatment with degludec was associated with greater opportunity to reach target FPG without an increased risk of nocturnal hypoglycemia. Disclosure C.H. Wysham: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi. Consultant; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Insulet Corporation, Novo Nordisk Inc., Sanofi. W. Lane: Advisory Panel; Self; Novo Nordisk A/S, Insulet Corporation, Intarcia Therapeutics, Inc., Sanofi. Research Support; Self; Novo Nordisk A/S, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Sanofi, Dexcom, Inc.. Speaker9s Bureau; Self; Novo Nordisk A/S, Insulet Corporation. S. Ladelund: Employee; Self; Novo Nordisk A/S, Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Technical University of Denmark. Research Support; Self; Metropolitan University College, Denmark. D. Tutkunkardas: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. S. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Takeda, Sanofi-Aventis, Boehringer Ingelheim GmbH. Consultant; Self; Eli Lilly and Company, Novo Nordisk A/S. Speaker9s Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Merck Sharp & Dohme Corp., Takeda, AstraZeneca, Boehringer Ingelheim GmbH.

  • Relationship between A1C and Hypoglycemia Risk in Individual Patients Comparing Insulin Degludec with Insulin Glargine U100
    Diabetes, 2018
    Co-Authors: Athena Philis-tsimikas, Carol H. Wysham, Wendy Gwirtzman Lane, Ulrik Pedersen-bjergaard, Lars Bardtrum, Signe Harring Østoft, Simon Heller
    Abstract:

    Targeting a lower A1C may increase the hypoglycemia risk in patients with diabetes. To investigate the relationship between A1C and hypoglycemia risk on an individual level, this post-hoc analysis used data from two double-blind, randomized, treat-to-target, two-period (32 weeks each) crossover trials of insulin degludec (degludec) vs. insulin glargine 100 units/mL (glargine U100) in patients with type 1 (T1D; SWITCH 1, n=501) or type 2 diabetes (T2D; SWITCH 2, n=721). For each patient at each visit, A1C was linked with the number of hypoglycemic events (blood glucose-confirmed [ In conclusion, lowering A1C led to a higher hypoglycemia risk; however, the lower incremental hypoglycemia risk with degludec vs. glargine U100 may allow for a lower A1C target in both T1D and T2D with degludec than with glargine U100 in clinical practice, when hypoglycemia is a limiting factor for glycemic control. Disclosure A. Philis-Tsimikas: Research Support; Self; Dexcom, Inc.. Advisory Panel; Self; Dexcom, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Novo Nordisk A/S, Sanofi, Mylan. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc.. Stock/Shareholder; Spouse/Partner; Esperion Therapeutics, Ionis Pharmaceuticals, Inc.. Advisory Panel; Self; AstraZeneca. W. Lane: Advisory Panel; Self; Novo Nordisk A/S, Insulet Corporation, Intarcia Therapeutics, Inc., Sanofi. Research Support; Self; Novo Nordisk A/S, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Sanofi, Dexcom, Inc.. Speaker9s Bureau; Self; Novo Nordisk A/S, Insulet Corporation. U. Pedersen-Bjergaard: Advisory Panel; Self; Novo Nordisk A/S. Consultant; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Advisory Panel; Self; Sanofi-Aventis. Consultant; Self; Medtronic. C.H. Wysham: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi. Consultant; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Insulet Corporation, Novo Nordisk Inc., Sanofi. L. Bardtrum: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. S.H. Ostoft: Employee; Self; Novo Nordisk A/S. S. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Takeda, Sanofi-Aventis, Boehringer Ingelheim GmbH. Consultant; Self; Eli Lilly and Company, Novo Nordisk A/S. Speaker9s Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Merck Sharp & Dohme Corp., Takeda, AstraZeneca, Boehringer Ingelheim GmbH.

Ildiko Lingvay - One of the best experts on this subject based on the ideXlab platform.

  • 2185-PUB: Once-Weekly Semaglutide 1mg vs. Empagliflozin 25mg as Add-On to Metformin Monotherapy in Patients with Type 2 Diabetes: A Meta-regression Analysis of Individual Patient Data
    Diabetes, 2020
    Co-Authors: Ildiko Lingvay, Andrei-mircea Catarig, Anna Sandberg, Jack Lawson, Matthew Capehorn, Pierre Johansen, Robert D. Shaw, Abby Paine
    Abstract:

    There are no published head-to-head trials of once-weekly semaglutide 1 mg vs. once-daily empagliflozin 25 mg in type 2 diabetes (T2D). We indirectly compared the pooled semaglutide arms in SUSTAIN 2, 3 and 8 with the empagliflozin arm in PIONEER 2 using individual patient data, for those on metformin monotherapy. Although all trials had similar inclusion criteria and duration, meta-regression analyses adjusting for effect modifiers and prognostic factors further controlled for differences in design and population. Mean baseline characteristics were similar with semaglutide and empagliflozin (age: 56 vs. 58 years, diabetes duration: 7 vs. 8 years, BMI: 33 vs. 33 kg/m2, HbA1c: 8.2% vs. 8.1%, respectively). Semaglutide reduced mean HbA1c by -1.4 vs. -0.8%-point with empagliflozin (p Disclosure I. Lingvay: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk A/S, Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Other Relationship; Self; Novo Nordisk A/S. A. Catarig: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. A. Sandberg: None. J. Lawson: Employee; Self; Novo Nordisk A/S. M. Capehorn: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk A/S. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk A/S. P. Johansen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. R.D. Shaw: Consultant; Self; Novo Nordisk A/S. A. Paine: Consultant; Self; Novo Nordisk A/S. Funding Novo Nordisk A/S

  • 2187-PUB: Identifying Risk Predictors for Gastrointestinal Adverse Events with Once-Weekly Semaglutide
    Diabetes, 2020
    Co-Authors: Tina Vilsbøll, Kajsa Kvist, Signe Harring, Ingrid Holst, Filip K. Knop, Ildiko Lingvay
    Abstract:

    Gastrointestinal adverse events (GI AEs) are common with glucagon-like peptide-1 receptor agonists (GLP-1RAs). We aimed to identify risk predictors for GI AEs with once-weekly semaglutide to support clinicians identify high-risk patients. Data from SUSTAIN 1-10 and two SUSTAIN Japanese trials were used to assess the effects of age, region, ethnicity, diabetes duration, gender, renal function, smoking status, HbA1c, body weight (BW), alanine aminotransferase and bilirubin on the incidence of GI AEs with semaglutide vs. non-GLP-1RA comparators (exenatide extended release, dulaglutide and liraglutide were excluded). Changes in HbA1c and BW were assessed by GI AE status. Frailty (age, renal impairment, smoking) and female gender were associated with marginally higher risk of GI AEs than non-frailty and male gender, regardless of treatment. With semaglutide, patients with lower baseline BW were at higher risk of GI AEs vs. those with higher BW. With comparators, lower baseline BW was associated with lower risk than higher BW. These results were confirmed by formal statistical analysis (data not shown). Semaglutide reduced HbA1c and BW across the trials, regardless of GI AEs (Figure). In conclusion, GI AEs are hard to predict although they tend to be more common in frail vs. non-frail patients and females vs. males, regardless of treatment. Semaglutide reduced HbA1c and BW regardless of the presence/absence of GI AEs. Disclosure T. Vilsboll: Advisory Panel; Self; AstraZeneca, Mundipharma International, Novo Nordisk A/S, Sun Pharmaceutical Industries Ltd. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Medscape, Merck Sharp & Dohme Corp., Sanofi. S. Harring: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. I. Lingvay: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk A/S, Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Other Relationship; Self; Novo Nordisk A/S. Funding Novo Nordisk A/S

  • 931-P: Optimal Treatment Intensification for Glycemic Control in Patients with T2D on Two Oral Agents: Real-World Comparison of GLP-1, OADs, and Insulin
    Diabetes, 2020
    Co-Authors: Cyrus Desouza, Michael L. Wolden, Andreas Ross Kirk, Kamal K. Mangla, Ildiko Lingvay
    Abstract:

    Introduction: Health care providers have many options for achieving glycemic control in individuals with T2D requiring treatment intensification. In this analysis from the PATHWAY study we address the question of optimal treatment choice, comparing intensification with additional oral antidiabetic drug (OAD), glucagon-like peptide-1 (GLP-1) analogs or insulin in individuals on 2 OADs. Methods: Electronic medical records and claims data were from IBM MarketScan Explorys Claims-EMR (index period: 3/1/13-10/31/18). Inclusion required ≥1 claim for 2 different OADs in the 180 days pre-index, ≥1 claim for another OAD/GLP-1/insulin (day 0; index date), ≥1 HbA1c and weight measurement 180 days post-index (+/− 90 days), and ≥1 HbA1c and weight measurement close to index date (baseline). Cohorts for GLP-1s vs. OADs and vs. insulin were propensity score matched pairwise by baseline variables and exact matched by HbA1c category (Figure). Results: Cohorts were well balanced across all baseline characteristics after matching. GLP-1 cohorts were significantly more likely to reach target HbA1c Conclusions: Our results support clinical decision-making at treatment intensification, indicating that individuals on 2 OADs are more likely to achieve targets with GLP-1s than with further OAD or insulin. Disclosure C. Desouza: Consultant; Self; AstraZeneca, Bayer AG, Novo Nordisk A/S. A. Kirk: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. K.K. Mangla: Employee; Self; Novo Nordisk A/S. M.L. Wolden: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Lingvay: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk A/S, Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Other Relationship; Self; Novo Nordisk A/S. Funding Novo Nordisk A/S

  • 54-OR: Oral Semaglutide vs. Empagliflozin Added On to Metformin Monotherapy in Uncontrolled Type 2 Diabetes: PIONEER 2
    Diabetes, 2019
    Co-Authors: Eduard Montanya, Ildiko Lingvay, Julio Rosenstock, Luis Henrique Santos Canani, Chaicharn Deerochanawong, Janusz Gumprecht, Søren Lindberg, Anette Luther Søndergaard, Marianne Bach Treppendahl, Helena W. Rodbard
    Abstract:

    The GLP-1 analog oral semaglutide (sema) 14 mg once daily (QD, N=411) was compared with the SGLT2i empagliflozin (empa) 25 mg QD (N=410) in patients (pts) with T2D uncontrolled on metformin in a 52-week randomized, open-label trial (NCT02863328). Endpoints included change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Two scientific questions were addressed through defining two estimands: treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product without rescue medication) in all randomized pts. Oral sema was superior to empa at reducing HbA1c at week 26; the difference was also significant at week 52 (Table). More patients achieved HbA1c In conclusion, oral sema provided superior reductions in HbA1c but not body weight at week 26, and significant reductions in HbA1c and body weight (trial product estimand) at week 52 vs. empa. Oral sema was well tolerated within the established safety profile of GLP-1RAs. Disclosure E. Montanya: Advisory Panel; Self; AstraZeneca, Novo Nordisk A/S, Servier. Consultant; Self; Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation. Employee; Spouse/Partner; Almirall, S.A. Research Support; Self; Menarini Group. Speaker9s Bureau; Self; Novo Nordisk A/S. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. L.H. Canani: Research Support; Self; Novo Nordisk Inc. Speaker9s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Sanofi. C. Deerochanawong: Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi-Aventis. J. Gumprecht: Advisory Panel; Self; Lilly Diabetes, Novo Nordisk A/S. Speaker9s Bureau; Self; AstraZeneca, Bioton, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Polfa Tarchomin S.A., Sanofi-Aventis, Servier. S. Lindberg: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Novo Nordisk A/S. I. Lingvay: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., MannKind Corporation. Consultant; Self; AstraZeneca, Novo Nordisk Inc., Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Research Support; Self; Merck & Co., Inc., Mylan, Novo Nordisk Inc., Pfizer Inc. Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. A.L. Sondergaard: Employee; Spouse/Partner; Novo Nordisk A/S. Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. M. Treppendahl: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. H.W. Rodbard: Advisory Panel; Self; Bayer US, Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Consultant; Spouse/Partner; Eli Lilly and Company. Consultant; Self; Gan & Lee Pharmaceuticals. Research Support; Self; Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker9s Bureau; Self; Merck & Co., Inc., Novo Nordisk Inc. Funding Novo Nordisk A/S

  • 55-OR: Oral Semaglutide vs. Liraglutide and Placebo in T2D: PIONEER 4
    Diabetes, 2019
    Co-Authors: Richard E. Pratley, Ildiko Lingvay, Aslam Amod, Michael A. Nauck, Søren Tetens Hoff, Karen Boje Pedersen, Takashi Kadowaki, Trine Saugstrup, Juris J. Meier
    Abstract:

    Patients (pts) with T2D uncontrolled on metformin ± SGLT2i were randomized to oral semaglutide (sema) 14 mg once daily (N=285), liraglutide (lira) 1.8 mg (N=284) or placebo (pbo, N=142) in a phase 3a, 52-week, double-blind, double-dummy trial (NCT02863419). Endpoints: Change (baseline to week 26) in HbA 1c (primary) and body weight (BW, confirmatory secondary). Two estimands addressed two efficacy-related questions: Treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product without rescue medication) in all randomized pts. Treatment policy estimand: Oral sema was non-inferior (margin 0.4%) to lira and superior to pbo in reducing HbA 1c , and superior to both in reducing BW at week 26 (Table). Differences in both HbA 1c and BW were significant at week 52. Trial product estimand: Oral sema gave significant reductions in HbA 1c and BW vs. lira and pbo at weeks 26 and 52. Oral sema had comparable tolerability to lira; 11% (oral sema) vs. 9% (lira) and 4% (pbo) prematurely discontinued trial product due to adverse events (primarily gastrointestinal; 5% [oral sema] vs. 3% [lira] discontinued due to nausea). In conclusion, oral sema was well tolerated in pts with T2D on metformin ± SGLT2i, was non-inferior vs. lira and superior vs. pbo in reducing HbA 1c , and was superior in reducing BW vs. both lira and pbo. The reduction in HbA 1c was significantly better vs. lira when evaluated by the trial product estimand. Disclosure R.E. Pratley: Consultant; Self; Sanofi US. Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Janssen Global Services, LLC., Janssen Research & Development, Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Mundipharma, Novo Nordisk Inc., Pfizer Inc., Sanofi, Takeda Development Center Americas, Inc. A. Amod: Advisory Panel; Self; Aspen Pharmacare, AstraZeneca, Novartis AG, Novo Nordisk A/S, Sanofi-Aventis. Consultant; Self; Servier. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Sanofi-Aventis, Servier. S.T. Hoff: Employee; Self; Novo Nordisk A/S. T. Kadowaki: Research Support; Self; Astellas Pharma Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Kowa Pharmaceutical, Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD, Nippon Boehringer Ingelheim, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. Speaker9s Bureau; Self; Astellas Pharma Inc., AstraZeneca, Mitsubishi Tanabe Pharma Corporation, MSD, Nippon Boehringer Ingelheim, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. I. Lingvay: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., MannKind Corporation. Consultant; Self; AstraZeneca, Novo Nordisk Inc., Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Research Support; Self; Merck & Co., Inc., Mylan, Novo Nordisk Inc., Pfizer Inc. Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. M.A. Nauck: Advisory Panel; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S. Research Support; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novo Nordisk A/S. Speaker9s Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sun Pharma. K. Pedersen: Employee; Self; Novo Nordisk A/S. T. Saugstrup: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Zealand Pharma A/S. J.J. Meier: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. Funding Novo Nordisk A/S

Kajsa Kvist - One of the best experts on this subject based on the ideXlab platform.

  • 2160-PUB: Development of an Evidence-Based Tool to Facilitate Individualized Treatment in the Clinic for Patients with Type 2 Diabetes
    Diabetes, 2020
    Co-Authors: Anna R. Kahkoska, Kajsa Kvist, John B. Buse, Signe Harring, Ingrid Holst, Filip K. Knop, Richard E. Pratley
    Abstract:

    Type 2 diabetes (T2D) is a heterogeneous disease with many therapies available. Current guidelines recommend individualized therapy, and this could be facilitated by using estimates of outcomes based on individual characteristics instead of population-level outcomes. There are challenges to defining and implementing individualized therapy in a data-driven and patient-oriented way. We propose criteria to aid implementation of individualized medicine, including: 1) robust insights based on high-quality clinical data, to guide treatment selection; 2) integration of patient-oriented outcomes with engagement of providers and patients; 3) provision of a user-friendly, efficient tool for use in the clinic. We are developing an interactive tool that draws on data from a wide range of randomized controlled trials, e.g., all treatment arms from the full phase 3a program for once-weekly semaglutide. The tool selects the appropriate trial from a database and shows the predicted change in outcomes on initiation/continuation with different therapies over 26-30 weeks. Estimates are based on characteristics such as age, BMI, and T2D duration (Figure). In conclusion, a tool such as this could help clinicians and patients use high-quality, large-scale data from contemporary trials to select individualized treatment regimens. Disclosure A.R. Kahkoska: Other Relationship; Self; Novo Nordisk A/S. J.B. Buse: Consultant; Self; Cirius Therapeutics, CSL Behring, Neurimmune. Research Support; Self; American Diabetes Association, National Institutes of Health, Novo Nordisk A/S, Patient-Centered Outcomes Research Institute, Sanofi, Tolerion, Inc., vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings, Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg Therapeutics, Novo Nordisk A/S, Senseonics, Inc, vTv Therapeutics, Zafgen, Inc. S. Harring: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. R.E. Pratley: Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Glytec, Janssen Scientific Affairs, LLC., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals Incorporated, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Funding Novo Nordisk A/S

  • 2187-PUB: Identifying Risk Predictors for Gastrointestinal Adverse Events with Once-Weekly Semaglutide
    Diabetes, 2020
    Co-Authors: Tina Vilsbøll, Kajsa Kvist, Signe Harring, Ingrid Holst, Filip K. Knop, Ildiko Lingvay
    Abstract:

    Gastrointestinal adverse events (GI AEs) are common with glucagon-like peptide-1 receptor agonists (GLP-1RAs). We aimed to identify risk predictors for GI AEs with once-weekly semaglutide to support clinicians identify high-risk patients. Data from SUSTAIN 1-10 and two SUSTAIN Japanese trials were used to assess the effects of age, region, ethnicity, diabetes duration, gender, renal function, smoking status, HbA1c, body weight (BW), alanine aminotransferase and bilirubin on the incidence of GI AEs with semaglutide vs. non-GLP-1RA comparators (exenatide extended release, dulaglutide and liraglutide were excluded). Changes in HbA1c and BW were assessed by GI AE status. Frailty (age, renal impairment, smoking) and female gender were associated with marginally higher risk of GI AEs than non-frailty and male gender, regardless of treatment. With semaglutide, patients with lower baseline BW were at higher risk of GI AEs vs. those with higher BW. With comparators, lower baseline BW was associated with lower risk than higher BW. These results were confirmed by formal statistical analysis (data not shown). Semaglutide reduced HbA1c and BW across the trials, regardless of GI AEs (Figure). In conclusion, GI AEs are hard to predict although they tend to be more common in frail vs. non-frail patients and females vs. males, regardless of treatment. Semaglutide reduced HbA1c and BW regardless of the presence/absence of GI AEs. Disclosure T. Vilsboll: Advisory Panel; Self; AstraZeneca, Mundipharma International, Novo Nordisk A/S, Sun Pharmaceutical Industries Ltd. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Medscape, Merck Sharp & Dohme Corp., Sanofi. S. Harring: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. I. Lingvay: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk A/S, Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Other Relationship; Self; Novo Nordisk A/S. Funding Novo Nordisk A/S

  • 11-LB: Nonsevere Hypoglycemia Predicts Increased Risk of Subsequent Severe Events in Patients with Type 2 Diabetes
    Diabetes, 2019
    Co-Authors: Simon Heller, Elise Hachmann-nielsen, Kajsa Kvist
    Abstract:

    It is well-known that higher rates of non-severe hypoglycemic episodes (NSHEs) associate with a greater risk of severe hypoglycemic episodes (SHEs) in patients with type 1 diabetes. We investigated whether a similar association existed in patients with type 2 diabetes (T2D). We explored if annual rate of NSHEs was associated with time to first SHE, cardiovascular (CV) death, time to first major adverse CV event (MACE), and all cause death in patients with T2D using data from LEADER, a CV outcomes trial with 9340 patients with T2D.We used a Cox proportional hazards model adjusted for randomized treatment arm, and annual rate of NSHE as a time-dependent covariate with three levels; A: Disclosure S.R. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Zealand Pharma A/S. Consultant; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. E. Hachmann-Nielsen: Employee; Self; Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Funding Novo Nordisk

  • 15-LB: Diabetes Duration Did Not Moderate the Reduction in Severe Hypoglycemia Seen with Degludec vs. Glargine U100 in DEVOTE
    Diabetes, 2019
    Co-Authors: Anastasia-stefania Alexopoulos, Elise Hachmann-nielsen, Kajsa Kvist, John B. Buse
    Abstract:

    Hypoglycemia is associated with significant morbidity in type 2 diabetes (T2D). Progression of T2D leads to declining counterregulatory responses and heightened hypoglycemia risk. In this secondary analysis of data from DEVOTE, a CVOT with 7637 patients with T2D at high risk of cardiovascular events, we investigated diabetes duration as a moderator of severe hypoglycemia (SH) with use of glargine U100 (IGlar U100) versus insulin degludec. Patients in DEVOTE were categorized by diabetes duration in years: Disclosure A. Alexopoulos: None. K. Kvist: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. E. Hachmann-Nielsen: Employee; Self; Novo Nordisk A/S. J.B. Buse: Consultant; Self; Neurimmune AG. Research Support; Self; AstraZeneca, National Center for Advancing Translational Sciences, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk A/S, Sanofi, vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg, Novo Nordisk A/S, Senseonics, vTv Therapeutics, Zafgen, Inc. Funding Novo Nordisk A/S

  • Glycemic Variability Associated with Time Spent in Hypoglycemia in Type 1 Diabetes—Explorative Data in Real-World, Real-Time Continuous Glucose Monitoring
    Diabetes, 2018
    Co-Authors: Elise Hachmann-nielsen, Trine Bartholdy, C. B. Djurhuus, Kajsa Kvist
    Abstract:

    Glycemic variability has previously been associated with risk of hypoglycemia. Cornerstone4Care (C4C), a digital patient management program for diabetes mellitus, supports diabetes self-managing and captures patient data inclusive real-world real-time continuous glucose monitoring (CGM) data. The objective was to explore the association between glucose variability and time spent in hypoglycemia (TIH; percent time with interstitial glucose (IG) In conclusion, higher glucose variability (CV) based on CGM data from T1D was observed to increase the time spent in hypoglycemia. The increase seemed to occur with a CV around 30-36% and seemed to be more independent of mean IG. Data source: https://www.cornerstones4care.com/. Disclosure E. Hachmann-Nielsen: Employee; Self; Novo Nordisk A/S. T. Bartholdy: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. C. Djurhuus: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S.

Richard E. Pratley - One of the best experts on this subject based on the ideXlab platform.

  • 2160-PUB: Development of an Evidence-Based Tool to Facilitate Individualized Treatment in the Clinic for Patients with Type 2 Diabetes
    Diabetes, 2020
    Co-Authors: Anna R. Kahkoska, Kajsa Kvist, John B. Buse, Signe Harring, Ingrid Holst, Filip K. Knop, Richard E. Pratley
    Abstract:

    Type 2 diabetes (T2D) is a heterogeneous disease with many therapies available. Current guidelines recommend individualized therapy, and this could be facilitated by using estimates of outcomes based on individual characteristics instead of population-level outcomes. There are challenges to defining and implementing individualized therapy in a data-driven and patient-oriented way. We propose criteria to aid implementation of individualized medicine, including: 1) robust insights based on high-quality clinical data, to guide treatment selection; 2) integration of patient-oriented outcomes with engagement of providers and patients; 3) provision of a user-friendly, efficient tool for use in the clinic. We are developing an interactive tool that draws on data from a wide range of randomized controlled trials, e.g., all treatment arms from the full phase 3a program for once-weekly semaglutide. The tool selects the appropriate trial from a database and shows the predicted change in outcomes on initiation/continuation with different therapies over 26-30 weeks. Estimates are based on characteristics such as age, BMI, and T2D duration (Figure). In conclusion, a tool such as this could help clinicians and patients use high-quality, large-scale data from contemporary trials to select individualized treatment regimens. Disclosure A.R. Kahkoska: Other Relationship; Self; Novo Nordisk A/S. J.B. Buse: Consultant; Self; Cirius Therapeutics, CSL Behring, Neurimmune. Research Support; Self; American Diabetes Association, National Institutes of Health, Novo Nordisk A/S, Patient-Centered Outcomes Research Institute, Sanofi, Tolerion, Inc., vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings, Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg Therapeutics, Novo Nordisk A/S, Senseonics, Inc, vTv Therapeutics, Zafgen, Inc. S. Harring: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. R.E. Pratley: Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Glytec, Janssen Scientific Affairs, LLC., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals Incorporated, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Funding Novo Nordisk A/S

  • 1004-P: Oral Semaglutide vs. Placebo in Patients with Type 2 Diabetes and Moderate Renal Impairment: PIONEER 5
    Diabetes, 2019
    Co-Authors: Ofri Mosenzon, Simon Heller, Richard E. Pratley, Signe Rosenlund, Jan W. Eriksson, Thozhukat Sathyapalan, Thalia Marie Blicher, Ole H. Hels, Cyrus Desouza
    Abstract:

    Patients (pts) with T2D and renal impairment have limited glucose-lowering treatment options. Oral semaglutide (sema) 14 mg once daily (N=163) was compared with placebo (pbo, N=161) in a 26-week, randomized, phase 3a trial (NCT02827708) in pts with T2D and moderate renal impairment (eGFR 30-59 mL/min/1.73 m2), receiving 1-2 glucose-lowering agents (could include basal insulin). Endpoints: change in HbA1c (primary) and body weight (BW, secondary) to week 26. Two estimands were defined: treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product without rescue medication) in all randomized pts. Oral sema was superior to (treatment policy) and significantly better than (trial product) pbo in reducing HbA1c and BW (Table). More pts reached HbA1c, BW loss, and composite targets with oral sema. At follow-up, eGFR was unchanged. Fewer pts on oral sema required rescue medication (4 vs. 10%). Adverse events were more frequent with oral sema (74 vs. 65%), most often mild/moderate nausea (19 vs. 7%). More patients on oral sema prematurely discontinued trial product (15 vs. 5%), mainly due to nausea and vomiting. In conclusion, in pts with T2D and moderate renal impairment, oral sema provided superior glycemic control and BW loss compared to pbo at 26 weeks, did not appear to affect renal function, and was well tolerated in line with the population and GLP-1RA class. Disclosure O. Mosenzon: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi. Research Support; Self; AstraZeneca, Novo Nordisk Inc. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis. S. Rosenlund: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. J.W. Eriksson: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Merck Sharp & Dohme Corp., Novo Nordisk A/S. Research Support; Self; AstraZeneca, Novo Nordisk A/S. S.R. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Zealand Pharma A/S. Consultant; Self; Novo Nordisk A/S. Speaker9s Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. R.E. Pratley: Consultant; Self; Sanofi US. Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Janssen Global Services, LLC., Janssen Research & Development, Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Mundipharma, Novo Nordisk Inc., Pfizer Inc., Sanofi, Takeda Development Center Americas, Inc. T. Sathyapalan: Speaker9s Bureau; Self; Novo Nordisk Foundation. Other Relationship; Self; Bristol-Myers Squibb Company, Eli Lilly and Company, Sanofi-Aventis. T.M. Blicher: Employee; Self; Novo Nordisk A/S. O.H. Hels: Employee; Self; Novo Nordisk A/S. C. Desouza: Consultant; Self; Novo Nordisk A/S, Sanofi US. Funding Novo Nordisk A/S

  • 55-OR: Oral Semaglutide vs. Liraglutide and Placebo in T2D: PIONEER 4
    Diabetes, 2019
    Co-Authors: Richard E. Pratley, Ildiko Lingvay, Aslam Amod, Michael A. Nauck, Søren Tetens Hoff, Karen Boje Pedersen, Takashi Kadowaki, Trine Saugstrup, Juris J. Meier
    Abstract:

    Patients (pts) with T2D uncontrolled on metformin ± SGLT2i were randomized to oral semaglutide (sema) 14 mg once daily (N=285), liraglutide (lira) 1.8 mg (N=284) or placebo (pbo, N=142) in a phase 3a, 52-week, double-blind, double-dummy trial (NCT02863419). Endpoints: Change (baseline to week 26) in HbA 1c (primary) and body weight (BW, confirmatory secondary). Two estimands addressed two efficacy-related questions: Treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product without rescue medication) in all randomized pts. Treatment policy estimand: Oral sema was non-inferior (margin 0.4%) to lira and superior to pbo in reducing HbA 1c , and superior to both in reducing BW at week 26 (Table). Differences in both HbA 1c and BW were significant at week 52. Trial product estimand: Oral sema gave significant reductions in HbA 1c and BW vs. lira and pbo at weeks 26 and 52. Oral sema had comparable tolerability to lira; 11% (oral sema) vs. 9% (lira) and 4% (pbo) prematurely discontinued trial product due to adverse events (primarily gastrointestinal; 5% [oral sema] vs. 3% [lira] discontinued due to nausea). In conclusion, oral sema was well tolerated in pts with T2D on metformin ± SGLT2i, was non-inferior vs. lira and superior vs. pbo in reducing HbA 1c , and was superior in reducing BW vs. both lira and pbo. The reduction in HbA 1c was significantly better vs. lira when evaluated by the trial product estimand. Disclosure R.E. Pratley: Consultant; Self; Sanofi US. Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Janssen Global Services, LLC., Janssen Research & Development, Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Mundipharma, Novo Nordisk Inc., Pfizer Inc., Sanofi, Takeda Development Center Americas, Inc. A. Amod: Advisory Panel; Self; Aspen Pharmacare, AstraZeneca, Novartis AG, Novo Nordisk A/S, Sanofi-Aventis. Consultant; Self; Servier. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Sanofi-Aventis, Servier. S.T. Hoff: Employee; Self; Novo Nordisk A/S. T. Kadowaki: Research Support; Self; Astellas Pharma Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Kowa Pharmaceutical, Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD, Nippon Boehringer Ingelheim, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. Speaker9s Bureau; Self; Astellas Pharma Inc., AstraZeneca, Mitsubishi Tanabe Pharma Corporation, MSD, Nippon Boehringer Ingelheim, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. I. Lingvay: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., MannKind Corporation. Consultant; Self; AstraZeneca, Novo Nordisk Inc., Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Research Support; Self; Merck & Co., Inc., Mylan, Novo Nordisk Inc., Pfizer Inc. Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. M.A. Nauck: Advisory Panel; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S. Research Support; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novo Nordisk A/S. Speaker9s Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sun Pharma. K. Pedersen: Employee; Self; Novo Nordisk A/S. T. Saugstrup: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Zealand Pharma A/S. J.J. Meier: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. Funding Novo Nordisk A/S

  • Cardiovascular (CV) Safety and Severe Hypoglycemia Benefit of Insulin Degludec vs. Insulin Glargine U100 in Older Patients (=65 Years) with Type 2 Diabetes (T2D)—Observations from DEVOTE
    Diabetes, 2018
    Co-Authors: Richard E. Pratley, Edward Franek, Scott S. Emerson, Matthew P. Gilbert, Steven P. Marso, Darren K. Mcguire, Thomas R. Pieber, Neil R. Poulter, Charlotte T. Hansen, Melissa V. Hansen
    Abstract:

    There is limited comparative evidence for the CV safety and hypoglycemia risk of basal insulins in older patients with T2D. This secondary analysis from DEVOTE investigated the CV safety and severe hypoglycemia risk of insulin degludec (degludec) vs. insulin glargine 100 units/mL (glargine U100) in older patients (65-74 and ?75 years age groups). Data from DEVOTE (a treat-to-target, randomized, double-blind trial evaluating 7637 patients with T2D over a median period of 2 years at high risk of CV events) were stratified by three age groups. At baseline, A1C, fasting plasma glucose and estimated glomerular filtration rates decreased with increasing age. Older patients had a higher risk of major adverse cardiovascular events (MACE), all-cause mortality and severe hypoglycemia, regardless of treatment. Treatment differences for MACE, all-cause mortality and severe hypoglycemia were similar across age groups (Figure), with no significant interactions between treatment and age group. Degludec was associated with a lower risk of severe hypoglycemia vs. glargine U100, regardless of age. This analysis supported the CV safety of degludec and demonstrated a lower risk of severe hypoglycemia vs. glargine U100 in older patients with T2D. Disclosure R.E. Pratley: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Inc., GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Pfizer Inc., Sanofi-Aventis, Takeda Development Center Americas, Inc. S.S. Emerson: Consultant; Self; Bayer AG, CTI BioPharma, Arena Pharmaceuticals, SFJ Pharmaceuticals Group, Genentech, Inc., GlaxoSmithKline plc., Janssen Research & Development, Novartis AG, Novo Nordisk A/S, Pfizer Inc., Roche Pharma, Allergan, AstraZeneca, Coherus Biosciences Inc, Emmaus Life Sciences Inc., Indivior, Sandoz, Seattle Genetics. Research Support; Self; National Heart, Lung, and Blood Institute. E. Franek: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Novo Nordisk A/S. Speaker9s Bureau; Self; AstraZeneca, Bristol-Myers Squibb Company, Boehringer Ingelheim GmbH, Eli Lilly and Company, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Servier. M.P. Gilbert: Consultant; Self; Sanofi US, Novo Nordisk A/S. S.P. Marso: Consultant; Self; Abbott Vascular, Novo Nordisk A/S, University of Oxford, AstraZeneca, Bristol-Myers Squibb Company. Research Support; Self; Novo Nordisk A/S, The Medicines Company, Terumo Medical Corporation. D.K. McGuire: Consultant; Self; AstraZeneca, Sanofi-Aventis, Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Pfizer Inc., Novo Nordisk A/S. Research Support; Self; AstraZeneca, Sanofi-Aventis, Janssen Pharmaceuticals, Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Lexicon Pharmaceuticals, Inc., Eisai Inc., GlaxoSmithKline plc., Esperion Therapeutics. T.R. Pieber: Consultant; Self; Arecor, AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Employee; Self; CBmed. Research Support; Self; Novo Nordisk A/S, AstraZeneca. N.R. Poulter: Advisory Panel; Self; AstraZeneca, Novo Nordisk A/S, Amgen Inc.. Research Support; Self; Servier. Speaker9s Bureau; Self; AstraZeneca, Novo Nordisk A/S, Amgen Inc., Servier. Other Relationship; Self; International Society of Hypertension. C.T. Hansen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. M.V. Hansen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. T. Mark: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. A.C. Moses: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. B. Zinman: Consultant; Self; Novo Nordisk A/S, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi, Merck & Co., Inc., Abbott.

  • Chronic Kidney Disease (CKD) and Risk of Mortality, Cardiovascular (CV) Events, and Severe Hypoglycemia in Type 2 Diabetes (T2D)-DEVOTE Results
    Diabetes, 2018
    Co-Authors: Aslam Amod, Richard E. Pratley, Scott S. Emerson, Steven P. Marso, Darren K. Mcguire, Thomas R. Pieber, Melissa V. Hansen, Rodica Pop-busui, Bernard Zinman, Ting Jia
    Abstract:

    T2D is associated with an increased risk of cardiovascular disease (CVD) and CKD. CKD is a known risk factor for major adverse cardiovascular events (MACE), all-cause mortality and hypoglycemia. This secondary, pooled analysis from DEVOTE examined whether baseline CKD stages were associated with an increased risk of MACE, all-cause mortality or severe hypoglycemia in T2D patients. DEVOTE was a treat-to-target, randomized, double-blind trial in 7637 patients with T2D at high CV risk, treated once daily with insulin degludec or insulin glargine 100 units/mL. According to baseline CKD stages (CKD stage 2: n=3118; stage 3: n=2704; stages 4+5: n=214), more patients had a history of CVD (CKD stages 3–5), were older and had lower A1C vs. those with normal kidney function (normal + CKD stage 1, n=1486). Risk of MACE and all-cause mortality was significantly higher (p Disclosure A. Amod: Advisory Panel; Self; Novo Nordisk A/S, AstraZeneca, Merck Sharp & Dohme Corp., Merck Serono, Boehringer Ingelheim Pharmaceuticals, Inc., Aspen Pharmacare, Sanofi-Aventis. Consultant; Self; Servier, Medscheme, Discovery Health. Speaker9s Bureau; Self; Novo Nordisk A/S, AstraZeneca, Merck Sharp & Dohme Corp., Merck Serono, Boehringer Ingelheim Pharmaceuticals, Inc., Aspen Pharmacare, Sanofi-Aventis, Novartis AG, Ascendis Health, Cipla Medpro. S.S. Emerson: Consultant; Self; Bayer AG, CTI BioPharma, Arena Pharmaceuticals, SFJ Pharmaceuticals Group, Genentech, Inc., GlaxoSmithKline plc., Janssen Research & Development, Novartis AG, Novo Nordisk A/S, Pfizer Inc., Roche Pharma, Allergan, AstraZeneca, Coherus Biosciences Inc, Emmaus Life Sciences Inc., Indivior, Sandoz, Seattle Genetics. Research Support; Self; National Heart, Lung, and Blood Institute. S.P. Marso: Consultant; Self; Abbott Vascular, Novo Nordisk A/S, University of Oxford, AstraZeneca, Bristol-Myers Squibb Company. Research Support; Self; Novo Nordisk A/S, The Medicines Company, Terumo Medical Corporation. D.K. McGuire: Consultant; Self; AstraZeneca, Sanofi-Aventis, Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Pfizer Inc., Novo Nordisk A/S. Research Support; Self; AstraZeneca, Sanofi-Aventis, Janssen Pharmaceuticals, Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Lexicon Pharmaceuticals, Inc., Eisai Inc., GlaxoSmithKline plc., Esperion Therapeutics. T.R. Pieber: Consultant; Self; Arecor, AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Employee; Self; CBmed. Research Support; Self; Novo Nordisk A/S, AstraZeneca. R. Pop-Busui: Research Support; Self; AstraZeneca. R.E. Pratley: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Inc., GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Pfizer Inc., Sanofi-Aventis, Takeda Development Center Americas, Inc. B. Zinman: Consultant; Self; Novo Nordisk A/S, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi, Merck & Co., Inc., Abbott. M.V. Hansen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. T. Jia: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. T. Mark: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. N.R. Poulter: Advisory Panel; Self; AstraZeneca, Novo Nordisk A/S, Amgen Inc.. Research Support; Self; Servier. Speaker9s Bureau; Self; AstraZeneca, Novo Nordisk A/S, Amgen Inc., Servier. Other Relationship; Self; International Society of Hypertension.

Carol H. Wysham - One of the best experts on this subject based on the ideXlab platform.

  • target fasting plasma glucose fpg without nocturnal hypoglycemia in patients with type 1 diabetes or type 2 diabetes results from switch trials
    Diabetes, 2018
    Co-Authors: Carol H. Wysham, Wendy Lane, Steen Ladelund, Deniz Tutkunkardas, Simon Heller
    Abstract:

    Insulin degludec (degludec) is a basal insulin that results in a lower FPG than insulin glargine 100 units/mL (glargine U100), which may increase the risk of nocturnal hypoglycemia in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D). This post-hoc analysis investigated the proportion of patients with T1D or T2D treated with degludec or glargine U100 meeting the ADA recommended upper limit of the pre-meal plasma glucose goal of In conclusion, compared with glargine U100, treatment with degludec was associated with greater opportunity to reach target FPG without an increased risk of nocturnal hypoglycemia. Disclosure C.H. Wysham: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi. Consultant; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Insulet Corporation, Novo Nordisk Inc., Sanofi. W. Lane: Advisory Panel; Self; Novo Nordisk A/S, Insulet Corporation, Intarcia Therapeutics, Inc., Sanofi. Research Support; Self; Novo Nordisk A/S, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Sanofi, Dexcom, Inc.. Speaker9s Bureau; Self; Novo Nordisk A/S, Insulet Corporation. S. Ladelund: Employee; Self; Novo Nordisk A/S, Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Technical University of Denmark. Research Support; Self; Metropolitan University College, Denmark. D. Tutkunkardas: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. S. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Takeda, Sanofi-Aventis, Boehringer Ingelheim GmbH. Consultant; Self; Eli Lilly and Company, Novo Nordisk A/S. Speaker9s Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Merck Sharp & Dohme Corp., Takeda, AstraZeneca, Boehringer Ingelheim GmbH.

  • Target Fasting Plasma Glucose (FPG) without Nocturnal Hypoglycemia in Patients with Type 1 Diabetes or Type 2 Diabetes—Results from SWITCH Trials
    Diabetes, 2018
    Co-Authors: Carol H. Wysham, Wendy Lane, Steen Ladelund, Deniz Tutkunkardas, Simon Heller
    Abstract:

    Insulin degludec (degludec) is a basal insulin that results in a lower FPG than insulin glargine 100 units/mL (glargine U100), which may increase the risk of nocturnal hypoglycemia in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D). This post-hoc analysis investigated the proportion of patients with T1D or T2D treated with degludec or glargine U100 meeting the ADA recommended upper limit of the pre-meal plasma glucose goal of In conclusion, compared with glargine U100, treatment with degludec was associated with greater opportunity to reach target FPG without an increased risk of nocturnal hypoglycemia. Disclosure C.H. Wysham: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi. Consultant; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Insulet Corporation, Novo Nordisk Inc., Sanofi. W. Lane: Advisory Panel; Self; Novo Nordisk A/S, Insulet Corporation, Intarcia Therapeutics, Inc., Sanofi. Research Support; Self; Novo Nordisk A/S, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Sanofi, Dexcom, Inc.. Speaker9s Bureau; Self; Novo Nordisk A/S, Insulet Corporation. S. Ladelund: Employee; Self; Novo Nordisk A/S, Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Technical University of Denmark. Research Support; Self; Metropolitan University College, Denmark. D. Tutkunkardas: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. S. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Takeda, Sanofi-Aventis, Boehringer Ingelheim GmbH. Consultant; Self; Eli Lilly and Company, Novo Nordisk A/S. Speaker9s Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Merck Sharp & Dohme Corp., Takeda, AstraZeneca, Boehringer Ingelheim GmbH.

  • Relationship between A1C and Hypoglycemia Risk in Individual Patients Comparing Insulin Degludec with Insulin Glargine U100
    Diabetes, 2018
    Co-Authors: Athena Philis-tsimikas, Carol H. Wysham, Wendy Gwirtzman Lane, Ulrik Pedersen-bjergaard, Lars Bardtrum, Signe Harring Østoft, Simon Heller
    Abstract:

    Targeting a lower A1C may increase the hypoglycemia risk in patients with diabetes. To investigate the relationship between A1C and hypoglycemia risk on an individual level, this post-hoc analysis used data from two double-blind, randomized, treat-to-target, two-period (32 weeks each) crossover trials of insulin degludec (degludec) vs. insulin glargine 100 units/mL (glargine U100) in patients with type 1 (T1D; SWITCH 1, n=501) or type 2 diabetes (T2D; SWITCH 2, n=721). For each patient at each visit, A1C was linked with the number of hypoglycemic events (blood glucose-confirmed [ In conclusion, lowering A1C led to a higher hypoglycemia risk; however, the lower incremental hypoglycemia risk with degludec vs. glargine U100 may allow for a lower A1C target in both T1D and T2D with degludec than with glargine U100 in clinical practice, when hypoglycemia is a limiting factor for glycemic control. Disclosure A. Philis-Tsimikas: Research Support; Self; Dexcom, Inc.. Advisory Panel; Self; Dexcom, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Novo Nordisk A/S, Sanofi, Mylan. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc.. Stock/Shareholder; Spouse/Partner; Esperion Therapeutics, Ionis Pharmaceuticals, Inc.. Advisory Panel; Self; AstraZeneca. W. Lane: Advisory Panel; Self; Novo Nordisk A/S, Insulet Corporation, Intarcia Therapeutics, Inc., Sanofi. Research Support; Self; Novo Nordisk A/S, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Sanofi, Dexcom, Inc.. Speaker9s Bureau; Self; Novo Nordisk A/S, Insulet Corporation. U. Pedersen-Bjergaard: Advisory Panel; Self; Novo Nordisk A/S. Consultant; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Advisory Panel; Self; Sanofi-Aventis. Consultant; Self; Medtronic. C.H. Wysham: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi. Consultant; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Insulet Corporation, Novo Nordisk Inc., Sanofi. L. Bardtrum: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. S.H. Ostoft: Employee; Self; Novo Nordisk A/S. S. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Takeda, Sanofi-Aventis, Boehringer Ingelheim GmbH. Consultant; Self; Eli Lilly and Company, Novo Nordisk A/S. Speaker9s Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Merck Sharp & Dohme Corp., Takeda, AstraZeneca, Boehringer Ingelheim GmbH.

  • Insulin Degludec Has Lower Hypoglycemia Risk than Insulin Glargine U100 in Older People with Type 2 Diabetes (T2D)
    Diabetes, 2018
    Co-Authors: Simon Heller, Carol H. Wysham, Charlotte T. Hansen, Melissa V. Hansen, J. Hans Devries, Brian M. Frier
    Abstract:

    Vulnerability to hypoglycemia increases with age. To further assess the safety of insulin in older patients, the risk of hypoglycemia was investigated post-hoc in the SWITCH 2 treat-to-target, 64-week, crossover trial. Patients with T2D and high risk of hypoglycemia were randomized, double-blind, to either degludec or insulin glargine U100 ± OADs. The primary endpoint was the number of positively adjudicated severe (external assistance) or symptomatic hypoglycemic events (plasma glucose 65 (n=270) years, baseline median [range] diabetes duration was 12.0 [1-40] vs. 15 [1-54] years, mean A1C was 7.7 vs. 7.4%, and mean eGFR was 87.0 vs. 63.7 mL/min/1.73m2. No significant differences in A1C reduction (degludec vs. glargine U100) were seen for patients ?65 and >65 years. During the maintenance period, degludec had a lower risk of hypoglycemia (overall/nocturnal symptomatic) vs. glargine U100 in patients ?65 (31/43%) and >65 years (30/41%) (Figure). The number of severe hypoglycemia episodes was not significantly lower. The adverse event rate was 3.2 and 3.3 events/patient-year for ?65 years and 3.5 and 4.1 events/patient-year for >65 years, for degludec and glargine U100, respectively. Degludec was safe and effective, and the frequency of hypoglycemia was lower than glargine U100 in patients ?65 and >65 years with T2D. Disclosure S.R. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Takeda, Sanofi-Aventis, Boehringer Ingelheim GmbH. Consultant; Self; Eli Lilly and Company, Novo Nordisk A/S. Speaker9s Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Merck Sharp & Dohme Corp., Takeda, AstraZeneca, Boehringer Ingelheim GmbH. J. DeVries: Research Support; Self; Dexcom, Inc., Medtronic, Novo Nordisk A/S. Advisory Panel; Self; Novo Nordisk A/S. Speaker9s Bureau; Self; Novo Nordisk A/S, Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Sanofi. Research Support; Self; Senseonics. Speaker9s Bureau; Self; Senseonics. Advisory Panel; Self; Zealand Pharma A/S. C.H. Wysham: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi. Consultant; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Insulet Corporation, Novo Nordisk Inc., Sanofi. C.T. Hansen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. M.V. Hansen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. B.M. Frier: Advisory Panel; Self; Novo Nordisk A/S, Eli Lilly and Company. Consultant; Self; Locemia Solutions, Zucara Therapeutics. Speaker9s Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Roche Pharma, AstraZeneca.

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