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Elisabeth Niemoeller - One of the best experts on this subject based on the ideXlab platform.

  • Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled by EstablishedBasal Insulin A 24-week, randomized, placebo-controlled comparison (GetGoal-L)
    2016
    Co-Authors: Matthew C Riddle, Elisabeth Niemoeller, Ronnie Aronson, Patrick Miossec, Lin Ping, Julio Rosenstock
    Abstract:

    OBJECTIVEdTo examine the efficacy and safety of adding the once-daily glucagon-like peptide-1 receptor agonist (GLP-1RA) Lixisenatide to established basal insulin therapy alone or together with metformin, in people with type 2 diabetes and elevated glycated hemoglobin (HbA1c). RESEARCHDESIGNANDMETHODSdWe conducted a double-blind, parallel-group, placebo-controlled trial. Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add Lixisenatide 20 mg or placebo for 24 weeks. Basal insulin dosage was unchanged except to limit hypoglycemia. HbA1c reduction from baseline was the primary end point. RESULTSdMean duration of diabetes was 12.5 years, duration of insulin use was 3.1 years, insulin dosage was 55 units/day, and baseline HbA1c was 8.4%. With Lixisenatide, the placebo-corrected change of HbA1c from baseline was –0.4 % (95%CI –0.6 to –0.2; P = 0.0002), andmean HbA1c at end point was 7.8%. HbA1c,7.0 % (53 mmol/mol) was attained by more Lixisenatide (28%) than placebo (12%; P, 0.0001) participants. Lixisenatide reduced plasma glucose levels after a standardized breakfast (placebo-corrected reduction, –3.8 mmol/L; P, 0.0001); seven

  • inadequately controlled by sulfonylurea with
    2016
    Co-Authors: Yutaka Seino, Elisabeth Niemoeller, Daisuke Yabe, Yukio Ikeda, Hiroki Takagi, Yukiko Onishi
    Abstract:

    Efficacy and safety of Lixisenatide in Japanese patients with type 2 diabetes mellitu

  • Lixisenatide treatment improves glycaemic control in asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea a randomized double blind placebo controlled 24 week trial getgoal m asia
    Diabetes-metabolism Research and Reviews, 2014
    Co-Authors: Chang Yu Pan, Ping Han, Xiaoming Liu, Shengli Yan, Ping Feng, Zhiguang Zhou, Hui Tian, Yang Jin Kui, Shuhua Shang, Elisabeth Niemoeller
    Abstract:

    Background This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, Lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea. Methods In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to Lixisenatide 20 µg once daily or placebo. The primary endpoint was absolute change in glycated haemoglobin (HbA1c) from baseline to week 24. Results A total of 391 patients were randomized. Lixisenatide significantly reduced HbA1c levels compared with placebo (LS mean difference: −0.36%, p = 0.0004). A significantly higher proportion of Lixisenatide-treated patients achieved HbA1c targets of <7% (p = 0.003) and ≤6.5% (p = 0.001) versus placebo. Lixisenatide was associated with a statistically significant reduction in 2-h postprandial plasma glucose after a standardized breakfast versus placebo (LS mean difference: −4.28 mmol/L, p < 0.0001) and a significant reduction in fasting plasma glucose (p = 0.0109). There was no difference in weight loss versus placebo, with a modest reduction in body weight reported for both groups (Lixisenatide: −1.50 kg, placebo: −1.24 kg; p = 0.296). The incidence of treatment-emergent adverse events (TEAEs) was 64.3% with Lixisenatide versus 47.4% with placebo, with serious TEAEs reported in 1.5% versus 2.1% of patients, respectively. The most common TEAE in the Lixisenatide group was nausea (16.3% vs 2.6% with placebo). The incidence of symptomatic hypoglycaemia was 5.6% with Lixisenatide treatment and 2.6% with placebo (p = 0.1321), with no severe symptomatic hypoglycaemia events reported. Conclusions In Asian patients with type 2 diabetes mellitus insufficiently controlled on metformin ± sulfonylurea, Lixisenatide significantly improved glycaemic control and was well tolerated during the 24-week study. © 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.

  • adding once daily Lixisenatide for type 2 diabetes inadequately controlled by established basal insulin a 24 week randomized placebo controlled comparison getgoal l
    Diabetes Care, 2013
    Co-Authors: Matthew C Riddle, Elisabeth Niemoeller, Ronnie Aronson, P D Home, Michel Marre, Patrick Miossec, Lin Ping, Julio Rosenstock
    Abstract:

    OBJECTIVE To examine the efficacy and safety of adding the once-daily glucagon-like peptide-1 receptor agonist (GLP-1RA) Lixisenatide to established basal insulin therapy alone or together with metformin, in people with type 2 diabetes and elevated glycated hemoglobin (HbA 1c ). RESEARCH DESIGN AND METHODS A double-blind, parallel-group, placebo-controlled trial. Patients ( n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add Lixisenatide 20 μg or placebo for 24 weeks. Basal insulin dosage was unchanged except to limit hypoglycemia. HbA 1c reduction from baseline was the primary end point. RESULTS Mean duration of diabetes was 12.5 years, duration of insulin use was 3.1 years, insulin dosage was 55 units/day, and baseline HbA 1c was 8.4%. With Lixisenatide, the placebo-corrected change of HbA 1c from baseline was –0.4% (95% CI –0.6 to –0.2; P = 0.0002), and mean HbA 1c at end point was 7.8%. HbA 1c P P P P = 0.012) were greater with Lixisenatide. Main adverse events (AEs) with Lixisenatide were gastrointestinal. Symptomatic hypoglycemia was 28% for Lixisenatide and 22% for placebo; 4 of 328 subjects (1.2%) had severe hypoglycemia with Lixisenatide vs. 0 of 167 with placebo. CONCLUSIONS By improving HbA 1c and postprandial hyperglycemia without weight gain in type 2 diabetes with inadequate glycemic control despite stable basal insulin, Lixisenatide may provide an alternative to rapid-acting insulin or other treatment options.

  • randomized double blind placebo controlled trial of the once daily glp 1 receptor agonist Lixisenatide in asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea getgoal l asia
    Diabetes Obesity and Metabolism, 2012
    Co-Authors: Yutaka Seino, Elisabeth Niemoeller, Akane Takami
    Abstract:

    Aims To assess the efficacy and safety of once-daily Lixisenatide versus placebo in Asian patients with type 2 diabetes insufficiently controlled on basal insulin ± sulfonylurea. Methods In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA1c 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received Lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily. The primary endpoint was HbA1c change from baseline to week 24. Results Once-daily Lixisenatide significantly improved HbA1c versus placebo (LS mean difference vs. placebo = −0.88% [95%CI= −1.116, −0.650]; p < 0.0001), and allowed more patients to achieve HbA1c <7.0% (35.6 vs. 5.2%) and ≤6.5% (17.8 vs. 1.3%). Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose. Lixisenatide was well tolerated; 86% of patients on Lixisenatide completed the study versus 92% on placebo. Ten (6.5%) Lixisenatide and 9 (5.7%) placebo patients experienced serious adverse events. More Lixisenatide patients [14 (9.1%)] discontinued for adverse events versus placebo [5 (3.2%)], mainly with gastrointestinal causes. Nausea and vomiting were reported in 39.6 and 18.2% of patients on Lixisenatide versus 4.5 and 1.9% on placebo. Symptomatic hypoglycaemia was more frequent with Lixisenatide (42.9%) versus placebo (23.6%), but was similar between groups (32.6 vs. 28.3%, respectively), in those not receiving sulfonylureas. No severe hypoglycaemia was reported. Conclusions In an Asian type 2 diabetes population insufficiently controlled by basal insulin ± sulfonylurea, once-daily Lixisenatide significantly improved glycaemic control, with a pronounced postprandial effect, and was well tolerated.

Julio Rosenstock - One of the best experts on this subject based on the ideXlab platform.

  • Newly Initiated and Continuously Titrated Basal Insulin Glargine A 24-Week, Randomized, Placebo-Controlled Study (GETGOAL-DUO-1)
    2016
    Co-Authors: Matthew C Riddle, Thomas Forst, Ronnie Aronson, Lin Ping, Leobardo Sauque-reyna, Elisabeth Souhami, Louise Silvestre, Julio Rosenstock
    Abstract:

    OBJECTIVEdWhen oral therapy for type 2 diabetes is ineffective, adding basal insulin improves glycemic control. However, when glycated hemoglobin (HbA1c) remains elevated because of postprandial hyperglycemia, the next therapeutic step is controversial. We examined the efficacy and safety of Lixisenatide in patients with HbA1c still elevated after initiation of insulin glargine. RESEARCH DESIGN AND METHODSdThis double-blind, parallel-group trial en-rolled patients with HbA1c 7–10 % despite oral therapy. Insulin glargine was added and system-atically titrated during a 12-week run-in, after which candidates with fasting glucose#7.8 mmol/L and HbA1c 7–9 % were randomized to Lixisenatide 20 mg or placebo for 24 weeks while insulin titration continued. The primary end point was HbA1c change after randomization. RESULTSdThe randomized population (n = 446) had mean diabetes duration of 9.2 years, BMI 31.8 kg/m2, and daily glargine dosage of 44 units. HbA1c had decreased during run-in from 8.6 to 7.6%; adding Lixisenatide further reduced HbA1c by 0.71 vs. 0.40 % with placebo (least squares mean difference, –0.32%; 95 % CI, –0.46 to –0.17; P, 0.0001). More participants attained HbA1c,7 % with Lixisenatide (56 vs. 39%; P, 0.0001). Lixisenatide reduced plasm

  • AddingOnce-DailyLixisenatideforType2 Diabetes Inadequately ControlledWith Newly Initiated and Continuously Titrated Basal Insulin Glargine
    2016
    Co-Authors: A -week, Thomas Forst, Ronnie Aronson, Matthew C Riddle, Lin Ping, Leobardo Sauque-reyna, Elisabeth Souhami, Louise Silvestre, Placebo-controlled Study, Julio Rosenstock
    Abstract:

    OBJECTIVEdWhen oral therapy for type 2 diabetes is ineffective, adding basal insulin improves glycemic control. However, when glycated hemoglobin (HbA1c) remains elevated because of postprandial hyperglycemia, the next therapeutic step is controversial. We examined the efficacy and safety of Lixisenatide in patients with HbA1c still elevated after initiation of insulin glargine. RESEARCH DESIGN AND METHODSdThis double-blind, parallel-group trial en-rolled patients with HbA1c 7–10 % despite oral therapy. Insulin glargine was added and system-atically titrated during a 12-week run-in, after which candidates with fasting glucose#7.8 mmol/L and HbA1c 7–9 % were randomized to Lixisenatide 20 mg or placebo for 24 weeks while insulin titration continued. The primary end point was HbA1c change after randomization. RESULTSdThe randomized population (n = 446) had mean diabetes duration of 9.2 years, BMI 31.8 kg/m2, and daily glargine dosage of 44 units. HbA1c had decreased during run-in from 8.6 to 7.6%; adding Lixisenatide further reduced HbA1c by 0.71 vs. 0.40 % with placebo (least squares mean difference, –0.32%; 95 % CI, –0.46 to –0.17; P, 0.0001). More participants attained HbA1c,7 % with Lixisenatide (56 vs. 39%; P, 0.0001). Lixisenatide reduced plasm

  • Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled by EstablishedBasal Insulin A 24-week, randomized, placebo-controlled comparison (GetGoal-L)
    2016
    Co-Authors: Matthew C Riddle, Elisabeth Niemoeller, Ronnie Aronson, Patrick Miossec, Lin Ping, Julio Rosenstock
    Abstract:

    OBJECTIVEdTo examine the efficacy and safety of adding the once-daily glucagon-like peptide-1 receptor agonist (GLP-1RA) Lixisenatide to established basal insulin therapy alone or together with metformin, in people with type 2 diabetes and elevated glycated hemoglobin (HbA1c). RESEARCHDESIGNANDMETHODSdWe conducted a double-blind, parallel-group, placebo-controlled trial. Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add Lixisenatide 20 mg or placebo for 24 weeks. Basal insulin dosage was unchanged except to limit hypoglycemia. HbA1c reduction from baseline was the primary end point. RESULTSdMean duration of diabetes was 12.5 years, duration of insulin use was 3.1 years, insulin dosage was 55 units/day, and baseline HbA1c was 8.4%. With Lixisenatide, the placebo-corrected change of HbA1c from baseline was –0.4 % (95%CI –0.6 to –0.2; P = 0.0002), andmean HbA1c at end point was 7.8%. HbA1c,7.0 % (53 mmol/mol) was attained by more Lixisenatide (28%) than placebo (12%; P, 0.0001) participants. Lixisenatide reduced plasma glucose levels after a standardized breakfast (placebo-corrected reduction, –3.8 mmol/L; P, 0.0001); seven

  • prandial options to advance basal insulin glargine therapy testing Lixisenatide plus basal insulin versus insulin glulisine either as basal plus or basal bolus in type 2 diabetes the getgoal duo 2 trial
    Diabetes Care, 2016
    Co-Authors: Julio Rosenstock, Sandro Gentile, Christine Royduval, Ronnie Aronson, M Hanefeld, Elisabeth Souhami, B Guerci, Francisco J Tinahones, Marek Wardecki, Riccardo Perfetti
    Abstract:

    OBJECTIVE To provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled on basal insulin glargine with or without 1–3 oral antidiabetic agents (OADs). RESEARCH DESIGN AND METHODS Patients were randomized to Lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization. Coprimary end points at 26 weeks were 1) noninferiority (95% CI upper bound RESULTS Baseline characteristics were similar between arms (n = 298, diabetes and basal insulin duration of 12.2 and 3.2 years, respectively; BMI 32.2 kg/m2). HbA1c improved from 8.5% to 7.9% (69 to 63 mmol/mol) with glargine optimization and further to 7.2%, 7.2%, and 7.0% (55, 55, and 53 mmol/mol) with Lixisenatide and glulisine once daily and thrice daily, respectively; all coprimary end points were met. Symptomatic hypoglycemia and body weight were lower in Lixisenatide versus glulisine patients. More gastrointestinal events occurred with Lixisenatide. CONCLUSIONS Short-acting glucagon-like peptide-1 receptor agonists as add-on to basal insulin may become a preferred treatment intensification option, attaining meaningful glycemic targets with fewer hypoglycemic events without weight gain versus basal-plus or basal-bolus in uncontrolled basal insulin-treated type 2 diabetes.

  • contrasting effects of Lixisenatide and liraglutide on postprandial glycemic control gastric emptying and safety parameters in patients with type 2 diabetes on optimized insulin glargine with or without metformin a randomized open label trial
    Diabetes Care, 2015
    Co-Authors: Juris J Meier, Julio Rosenstock, Agnes Hincelinmery, Christine Royduval, Astrid Delfolie, Hansveit Coester, Bjoern A Menge, Thomas Forst, Christoph Kapitza
    Abstract:

    OBJECTIVE This mechanistic trial compared the pharmacodynamics and safety of Lixisenatide and liraglutide in combination with optimized insulin glargine with/without metformin in type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS This was a multicenter, randomized, open-label, three-arm trial comparing Lixisenatide 20 µg and liraglutide 1.2 and 1.8 mg once daily for 8 weeks in combination with insulin glargine after optimized titration. The primary end point was change from baseline to week 8 in incremental area under the postprandial plasma glucose curve for 4 h after a standardized solid breakfast (AUC PPG 0030–0430 h ). Changes from baseline in gastric emptying, 24-h plasma glucose profile, HbA 1c , fasting plasma glucose (FPG), 24-h ambulatory heart rate and blood pressure, amylase and lipase levels, and adverse events (AEs) were also assessed. RESULTS In total, 142 patients were randomized and treated. Lixisenatide 20 µg achieved greater reductions of AUC PPG 0030−0430 h compared with liraglutide (marginal mean [95% one-sided CI] treatment difference, −6.0 [−7.8] h ⋅ mmol/L [−108.3 (−140.0) h ⋅ mg/dL] vs. liraglutide 1.2 mg and −4.6 [−6.3] h ⋅ mmol/L [−83.0 (−114.2) h ⋅ mg/dL] vs. liraglutide 1.8 mg; P P 1c was 6.2 ± 0.4% (44 ± 5 mmol/mol), 6.1 ± 0.3% (44 ± 4 mmol/mol), and 6.1 ± 0.3% (44 ± 4 mmol/mol) for Lixisenatide 20 µg and liraglutide 1.2 and 1.8 mg, respectively. At week 8, both liraglutide doses increased marginal mean ± SE 24-h heart rate from baseline by 9 ± 1 bpm vs. 3 ± 1 bpm with Lixisenatide ( P P CONCLUSIONS Lixisenatide and liraglutide improved glycemic control in optimized insulin glargine-treated T2D albeit with contrasting mechanisms of action and differing safety profiles.

Gabor Boka - One of the best experts on this subject based on the ideXlab platform.

  • beneficial effects of once daily Lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin getgoal s
    Journal of Diabetes and Its Complications, 2014
    Co-Authors: Julio Rosenstock, Patrick Miossec, Gabor Boka, M Hanefeld, Paramesh Shamanna, Kyung Wan Min, Tianyue Zhou, Isabel Muehlenbartmer, Robert E Ratner
    Abstract:

    Abstract Aims To assess efficacy and safety of Lixisenatide once-daily versus placebo in Type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU)±metformin. Methods In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received Lixisenatide 20μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs±metformin. Primary outcome was change in HbA 1c from baseline to Week 24. Results Lixisenatide provided a significant reduction in HbA 1c at Week 24 versus placebo (LS mean: −0.85% vs. −0.10%; p 1c Conclusions Once-daily Lixisenatide significantly improved glycemic control, with a pronounced postprandial effect, without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over 24 weeks.

  • efficacy and safety of Lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin a 24 week randomized open label active controlled study getgoal x
    Diabetes Care, 2013
    Co-Authors: Julio Rosenstock, Patrick Miossec, D Raccah, Laszlo Koranyi, Laura Maffei, Gabor Boka, John E Gerich
    Abstract:

    OBJECTIVE To compare efficacy and safety of Lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled with metformin. RESEARCH DESIGN AND METHODS Adults with diabetes inadequately controlled (HbA 1c 7–10%) with metformin were randomized to Lixisenatide 20 μg once daily ( n = 318) or exenatide 10 μg twice daily ( n = 316) in a 24-week (main period), open-label, parallel-group, multicenter study. The primary objective was a noninferiority assessment of Lixisenatide versus exenatide in HbA 1c change from baseline to week 24. RESULTS Lixisenatide once daily demonstrated noninferiority in HbA 1c reduction versus exenatide twice daily. The LS mean change was −0.79% (mean decrease 7.97 to 7.17%) for Lixisenatide versus −0.96% (mean ± SD 7.96 to 7.01%) for exenatide, and treatment difference was 0.17% (95% CI, 0.033–0.297), meeting a predefined noninferiority upper CI margin of 0.4%. Responder rate (HbA 1c P P CONCLUSIONS Add-on Lixisenatide once daily in type 2 diabetes inadequately controlled with metformin demonstrated noninferior improvements in HbA 1c , with slightly lower mean weight loss, lower incidence of hypoglycemia, and better gastrointestinal tolerability compared with exenatide twice daily.

  • efficacy and safety of the once daily glp 1 receptor agonist Lixisenatide in monotherapy a randomized double blind placebo controlled trial in patients with type 2 diabetes getgoal mono
    Diabetes Care, 2012
    Co-Authors: Vivian Fonseca, Patrick Miossec, D Raccah, Gabor Boka, Ricardo Alvaradoruiz, John E Gerich
    Abstract:

    OBJECTIVE To assess efficacy and safety of Lixisenatide monotherapy in type 2 diabetes. RESEARCH DESIGN AND METHODS Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy (HbA 1c 7–10%) allocated to one of four once-daily subcutaneous dose increase regimens: Lixisenatide 2-step (10 μg for 1 week, 15 μg for 1 week, and then 20 μg; n = 120), Lixisenatide 1-step (10 μg for 2 weeks and then 20 μg; n = 119), placebo 2-step ( n = 61), or placebo 1-step ( n = 61) (placebo groups were combined for analyses). Primary end point was HbA 1c change from baseline to week 12. RESULTS Once-daily Lixisenatide significantly improved HbA 1c (mean baseline 8.0%) in both groups (least squares mean change vs. placebo: −0.54% for 2-step, −0.66% for 1-step; P 1c P CONCLUSIONS Once-daily Lixisenatide monotherapy significantly improved glycemic control with a pronounced postprandial effect (75% reduction in glucose excursion) and was safe and well tolerated in type 2 diabetes.

  • dose dependent effects of the once daily glp 1 receptor agonist Lixisenatide in patients with type 2 diabetes inadequately controlled with metformin a randomized double blind placebo controlled trial
    Diabetic Medicine, 2010
    Co-Authors: Robert E Ratner, Julio Rosenstock, Gabor Boka
    Abstract:

    Diabet. Med. 27, 1024–1032 (2010) Abstract Aims  To evaluate the dose–response relationship of Lixisenatide (AVE0010), a glucagon-like peptide-1 (GLP-1) receptor agonist, in metformin-treated patients with Type 2 diabetes. Methods  Randomized, double-blind, placebo-controlled, parallel-group, 13 week study of 542 patients with Type 2 diabetes inadequately controlled [glycated haemoglobin (HbA1c) ≥ 7.0 and < 9.0% (≥ 53 and < 75 mmol/mol)] on metformin (≥ 1000 mg/day) treated with subcutaneous Lixisenatide doses of 5, 10, 20 or 30 μg once daily or twice daily or placebo. The primary end-point was change in HbA1c from baseline to 13 weeks in the intent-to-treat population. Results  Lixisenatide significantly improved mean HbA1c from a baseline of 7.55% (59.0 mmol/mol); respective mean reductions for 5, 10, 20 and 30 μg doses were 0.47, 0.50, 0.69 and 0.76% (5.1, 5.5, 7.5 and 8.3 mmol/mol), on once-daily and 0.65, 0.78, 0.75 and 0.87% (7.1, 8.5, 8.2 and 9.5 mmol/mol) on twice-daily administrations vs. 0.18% (2.0 mmol/mol) with placebo (all P < 0.01 vs. placebo). Target HbA1c < 7.0% (53 mmol/mol) at study end was achieved in 68% of patients receiving 20 and 30 μg once-daily Lixisenatide vs. 32% receiving placebo (P < 0.0001). Dose-dependent improvements were observed for fasting, postprandial and average self-monitored seven-point blood glucose levels. Weight changes ranged from −2.0 to −3.9 kg with Lixisenatide vs. −1.9 kg with placebo. The most frequent adverse event was mild-to-moderate nausea. Conclusions  Lixisenatide significantly improved glycaemic control in mildly hyperglycaemic patients with Type 2 diabetes on metformin. Dose–response relationships were seen for once- and twice-daily regimens, with similar efficacy levels, with a 20 μg once-daily dose of Lixisenatide demonstrating the best efficacy-to-tolerability ratio. This new, once-daily GLP-1 receptor agonist shows promise in the management of Type 2 diabetes to be defined further by ongoing long-term studies.

Akane Takami - One of the best experts on this subject based on the ideXlab platform.

  • randomized double blind placebo controlled trial of the once daily glp 1 receptor agonist Lixisenatide in asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea getgoal l asia
    Diabetes Obesity and Metabolism, 2012
    Co-Authors: Yutaka Seino, Elisabeth Niemoeller, Akane Takami
    Abstract:

    Aims To assess the efficacy and safety of once-daily Lixisenatide versus placebo in Asian patients with type 2 diabetes insufficiently controlled on basal insulin ± sulfonylurea. Methods In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA1c 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received Lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily. The primary endpoint was HbA1c change from baseline to week 24. Results Once-daily Lixisenatide significantly improved HbA1c versus placebo (LS mean difference vs. placebo = −0.88% [95%CI= −1.116, −0.650]; p < 0.0001), and allowed more patients to achieve HbA1c <7.0% (35.6 vs. 5.2%) and ≤6.5% (17.8 vs. 1.3%). Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose. Lixisenatide was well tolerated; 86% of patients on Lixisenatide completed the study versus 92% on placebo. Ten (6.5%) Lixisenatide and 9 (5.7%) placebo patients experienced serious adverse events. More Lixisenatide patients [14 (9.1%)] discontinued for adverse events versus placebo [5 (3.2%)], mainly with gastrointestinal causes. Nausea and vomiting were reported in 39.6 and 18.2% of patients on Lixisenatide versus 4.5 and 1.9% on placebo. Symptomatic hypoglycaemia was more frequent with Lixisenatide (42.9%) versus placebo (23.6%), but was similar between groups (32.6 vs. 28.3%, respectively), in those not receiving sulfonylureas. No severe hypoglycaemia was reported. Conclusions In an Asian type 2 diabetes population insufficiently controlled by basal insulin ± sulfonylurea, once-daily Lixisenatide significantly improved glycaemic control, with a pronounced postprandial effect, and was well tolerated.

  • p325 le Lixisenatide ameliore significativement l equilibre glycemique chez des patients asiatiques ayant un dt2 mal equilibre sous insuline basale su
    Diabetes & Metabolism, 2012
    Co-Authors: Yutaka Seino, Elisabeth Niemoeller, Akane Takami
    Abstract:

    Introduction Cette etude multicentrique de phase 3 de 24 semaines, randomisee, en double aveugle, controlee versus placebo en 2 bras paralleles a evalue l’efficacite et la tolerance du Lixisenatide chez des patients asiatiques ayant un DT2 non equilibre sous insuline basale ± SU. Materiels et methodes 311 patients (âge moyen : 58,4 ans, duree de diabete : 13,9 ans, IMC : 25,3 kg/m 2 , du Japon, de Coree du Sud, de Taiwan ou des Philippines). Ces patients anterieurement traites par insuline basale ± SU ont ete separes par randomisation en 2 groupes, un groupe Lixisenatide 20 ∞g en 1 prise (n = 154) et un groupe placebo (n = 157). Les groupes etaient globalement comparables a l’inclusion. Apres l’inclusion et 1 semaine de placebo en simple aveugle, les patients entraient dans une phase de 24 semaines de traitement en double aveugle, controlee versus placebo. Le critere principal etait la variation d’HbA1c entre l’inclusion et 24 semaines. Resultats Le Lixisenatide une fois par jour a ameliore significativement l’HbA1c vs le placebo (difference moyenne LS (Least Square = moindres carres) : −0,9 %). Davantage de patients sous Lixisenatide ont atteint une HbA1c − 6,5 % (17,8 %) et Conclusion Dans cette population asiatique de patients DT2 mal equilibres sous insuline basale ± SU, le Lixisenatide en une prise quotidienne a significativement ameliore l’equilibre glycemique avec un effet prononce sur la GJ et la GPP et a ete bien tolere.

Ronnie Aronson - One of the best experts on this subject based on the ideXlab platform.

  • Newly Initiated and Continuously Titrated Basal Insulin Glargine A 24-Week, Randomized, Placebo-Controlled Study (GETGOAL-DUO-1)
    2016
    Co-Authors: Matthew C Riddle, Thomas Forst, Ronnie Aronson, Lin Ping, Leobardo Sauque-reyna, Elisabeth Souhami, Louise Silvestre, Julio Rosenstock
    Abstract:

    OBJECTIVEdWhen oral therapy for type 2 diabetes is ineffective, adding basal insulin improves glycemic control. However, when glycated hemoglobin (HbA1c) remains elevated because of postprandial hyperglycemia, the next therapeutic step is controversial. We examined the efficacy and safety of Lixisenatide in patients with HbA1c still elevated after initiation of insulin glargine. RESEARCH DESIGN AND METHODSdThis double-blind, parallel-group trial en-rolled patients with HbA1c 7–10 % despite oral therapy. Insulin glargine was added and system-atically titrated during a 12-week run-in, after which candidates with fasting glucose#7.8 mmol/L and HbA1c 7–9 % were randomized to Lixisenatide 20 mg or placebo for 24 weeks while insulin titration continued. The primary end point was HbA1c change after randomization. RESULTSdThe randomized population (n = 446) had mean diabetes duration of 9.2 years, BMI 31.8 kg/m2, and daily glargine dosage of 44 units. HbA1c had decreased during run-in from 8.6 to 7.6%; adding Lixisenatide further reduced HbA1c by 0.71 vs. 0.40 % with placebo (least squares mean difference, –0.32%; 95 % CI, –0.46 to –0.17; P, 0.0001). More participants attained HbA1c,7 % with Lixisenatide (56 vs. 39%; P, 0.0001). Lixisenatide reduced plasm

  • AddingOnce-DailyLixisenatideforType2 Diabetes Inadequately ControlledWith Newly Initiated and Continuously Titrated Basal Insulin Glargine
    2016
    Co-Authors: A -week, Thomas Forst, Ronnie Aronson, Matthew C Riddle, Lin Ping, Leobardo Sauque-reyna, Elisabeth Souhami, Louise Silvestre, Placebo-controlled Study, Julio Rosenstock
    Abstract:

    OBJECTIVEdWhen oral therapy for type 2 diabetes is ineffective, adding basal insulin improves glycemic control. However, when glycated hemoglobin (HbA1c) remains elevated because of postprandial hyperglycemia, the next therapeutic step is controversial. We examined the efficacy and safety of Lixisenatide in patients with HbA1c still elevated after initiation of insulin glargine. RESEARCH DESIGN AND METHODSdThis double-blind, parallel-group trial en-rolled patients with HbA1c 7–10 % despite oral therapy. Insulin glargine was added and system-atically titrated during a 12-week run-in, after which candidates with fasting glucose#7.8 mmol/L and HbA1c 7–9 % were randomized to Lixisenatide 20 mg or placebo for 24 weeks while insulin titration continued. The primary end point was HbA1c change after randomization. RESULTSdThe randomized population (n = 446) had mean diabetes duration of 9.2 years, BMI 31.8 kg/m2, and daily glargine dosage of 44 units. HbA1c had decreased during run-in from 8.6 to 7.6%; adding Lixisenatide further reduced HbA1c by 0.71 vs. 0.40 % with placebo (least squares mean difference, –0.32%; 95 % CI, –0.46 to –0.17; P, 0.0001). More participants attained HbA1c,7 % with Lixisenatide (56 vs. 39%; P, 0.0001). Lixisenatide reduced plasm

  • Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled by EstablishedBasal Insulin A 24-week, randomized, placebo-controlled comparison (GetGoal-L)
    2016
    Co-Authors: Matthew C Riddle, Elisabeth Niemoeller, Ronnie Aronson, Patrick Miossec, Lin Ping, Julio Rosenstock
    Abstract:

    OBJECTIVEdTo examine the efficacy and safety of adding the once-daily glucagon-like peptide-1 receptor agonist (GLP-1RA) Lixisenatide to established basal insulin therapy alone or together with metformin, in people with type 2 diabetes and elevated glycated hemoglobin (HbA1c). RESEARCHDESIGNANDMETHODSdWe conducted a double-blind, parallel-group, placebo-controlled trial. Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add Lixisenatide 20 mg or placebo for 24 weeks. Basal insulin dosage was unchanged except to limit hypoglycemia. HbA1c reduction from baseline was the primary end point. RESULTSdMean duration of diabetes was 12.5 years, duration of insulin use was 3.1 years, insulin dosage was 55 units/day, and baseline HbA1c was 8.4%. With Lixisenatide, the placebo-corrected change of HbA1c from baseline was –0.4 % (95%CI –0.6 to –0.2; P = 0.0002), andmean HbA1c at end point was 7.8%. HbA1c,7.0 % (53 mmol/mol) was attained by more Lixisenatide (28%) than placebo (12%; P, 0.0001) participants. Lixisenatide reduced plasma glucose levels after a standardized breakfast (placebo-corrected reduction, –3.8 mmol/L; P, 0.0001); seven

  • prandial options to advance basal insulin glargine therapy testing Lixisenatide plus basal insulin versus insulin glulisine either as basal plus or basal bolus in type 2 diabetes the getgoal duo 2 trial
    Diabetes Care, 2016
    Co-Authors: Julio Rosenstock, Sandro Gentile, Christine Royduval, Ronnie Aronson, M Hanefeld, Elisabeth Souhami, B Guerci, Francisco J Tinahones, Marek Wardecki, Riccardo Perfetti
    Abstract:

    OBJECTIVE To provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled on basal insulin glargine with or without 1–3 oral antidiabetic agents (OADs). RESEARCH DESIGN AND METHODS Patients were randomized to Lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization. Coprimary end points at 26 weeks were 1) noninferiority (95% CI upper bound RESULTS Baseline characteristics were similar between arms (n = 298, diabetes and basal insulin duration of 12.2 and 3.2 years, respectively; BMI 32.2 kg/m2). HbA1c improved from 8.5% to 7.9% (69 to 63 mmol/mol) with glargine optimization and further to 7.2%, 7.2%, and 7.0% (55, 55, and 53 mmol/mol) with Lixisenatide and glulisine once daily and thrice daily, respectively; all coprimary end points were met. Symptomatic hypoglycemia and body weight were lower in Lixisenatide versus glulisine patients. More gastrointestinal events occurred with Lixisenatide. CONCLUSIONS Short-acting glucagon-like peptide-1 receptor agonists as add-on to basal insulin may become a preferred treatment intensification option, attaining meaningful glycemic targets with fewer hypoglycemic events without weight gain versus basal-plus or basal-bolus in uncontrolled basal insulin-treated type 2 diabetes.

  • efficacy and safety of Lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone getgoal p
    Diabetes Obesity and Metabolism, 2013
    Co-Authors: M Pinget, Ronald Goldenberg, E Niemoeller, I Muehlenbartmer, H Guo, Ronnie Aronson
    Abstract:

    Aims To compare the efficacy and safety of once-daily prandial Lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin. Methods This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period. Patients were randomized 2 : 1 to receive Lixisenatide 20 µg once daily or placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) at week 24. Results In total, 484 patients were randomized: 323 to Lixisenatide; 161 to placebo. After 24 weeks, Lixisenatide once daily significantly improved HbA1c (−0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%, respectively; p < 0.0001) and significantly improved fasting plasma glucose (−0.84 mmol/l vs. placebo; p < 0.0001). There was a small decrease in body weight with Lixisenatide once daily and a small increase with placebo, with no statistically significant difference between the two groups. Overall, Lixisenatide once daily was well tolerated, with a similar proportion of treatment-emergent adverse events (TEAEs) and serious TEAEs between groups (Lixisenatide: 72.4% and 2.5%; placebo: 72.7% and 1.9%). Symptomatic hypoglycaemia rates were also relatively low in both groups (Lixisenatide 3.4% and placebo 1.2%), with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable extension period. Conclusions Lixisenatide once daily significantly improved glycaemic control with a low risk of hypoglycaemia, and was well tolerated over 24 weeks and during the long-term, double-blind extension period in patients with T2DM insufficiently controlled on pioglitazone ± metformin.