Albiglutide

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Murray Stewart - One of the best experts on this subject based on the ideXlab platform.

  • Efficacy and safety of once-weekly GLP-1 receptor agonist Albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise
    Diabetologia, 2015
    Co-Authors: Michael A. Nauck, Murray Stewart, Fred Yang, Rickey R. Reinhardt, Caroline R Perry, Christopher Perkins, Angela Jones-leone, Marc Rendell
    Abstract:

    Aims/hypothesis Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated Albiglutide as monotherapy.

  • efficacy and tolerability of Albiglutide versus placebo or pioglitazone over 1 year in people with type 2 diabetes currently taking metformin and glimepiride harmony 5
    Diabetes Obesity and Metabolism, 2015
    Co-Authors: P D Home, Murray Stewart, Fred Yang, Caroline Perry, P Shamanna, M Miller, Molly C Carr
    Abstract:

    Aims To investigate the efficacy and tolerability of Albiglutide, a weekly glucagon-like peptide-1 receptor agonist, when added to metformin and glimepiride in a triple therapy regimen in people with type 2 diabetes mellitus. Methods This was a 156-week, randomized, double-blind, parallel-group, multicentre study. In the present paper we describe the primary results, namely those at 52 weeks. Adult participants (n = 685) were randomly assigned to Albiglutide (30 mg/week), pioglitazone (30 mg/day) or placebo. If needed, blinded uptitration of Albiglutide (to 50 mg/week) and pioglitazone (to 45 mg/day) was allowed. The participant's current dose of metformin (>1500 mg/day) was maintained throughout. The glimepiride dose (4 mg/day), standardized before randomization, could be decreased if persistent hypoglycaemia occurred. Results The week 52 model-adjusted difference in change of glycated haemoglobin (primary endpoint) for Albiglutide versus placebo was -0.87 [95% confidence interval (CI) –1.07, –0.68]%-units (p < 0.001), and for Albiglutide versus pioglitazone it was 0.25 (95% CI 0.10, 0.40)%-units; therefore, not non-inferior. In the Albiglutide group only, fasting plasma glucose reduced rapidly in the first 2 weeks. Confirmed hypoglycaemia occurred in 14% of participants on Albiglutide, 25% on pioglitazone and 14% on placebo. The mean (± standard error) weight change was −0.42 (±0.2) kg with Albiglutide, +4.4 (±0.2) kg (p < 0.001) with pioglitazone, and −0.40 (±0.4) kg with placebo and serious adverse events occurred in 6.3, 9.0 and 6.1% of participants in the respective groups. Injection site reactions occurred in 13% of participants on Albiglutide and resulted in treatment discontinuation for four participants (1.4%). Conclusions Albiglutide, as part of triple therapy, provided effective glucose-lowering and was generally well tolerated.

  • Efficacy and tolerability of Albiglutide versus placebo or pioglitazone over 1 year in people with type 2 diabetes currently taking metformin and glimepiride: HARMONY 5
    Diabetes obesity & metabolism, 2014
    Co-Authors: Philip Home, Murray Stewart, Fred Yang, P Shamanna, M Miller, Caroline R Perry, Molly C Carr
    Abstract:

    Aims To investigate the efficacy and tolerability of Albiglutide, a weekly glucagon-like peptide-1 receptor agonist, when added to metformin and glimepiride in a triple therapy regimen in people with type 2 diabetes mellitus. Methods This was a 156-week, randomized, double-blind, parallel-group, multicentre study. In the present paper we describe the primary results, namely those at 52 weeks. Adult participants (n = 685) were randomly assigned to Albiglutide (30 mg/week), pioglitazone (30 mg/day) or placebo. If needed, blinded uptitration of Albiglutide (to 50 mg/week) and pioglitazone (to 45 mg/day) was allowed. The participant's current dose of metformin (>1500 mg/day) was maintained throughout. The glimepiride dose (4 mg/day), standardized before randomization, could be decreased if persistent hypoglycaemia occurred. Results The week 52 model-adjusted difference in change of glycated haemoglobin (primary endpoint) for Albiglutide versus placebo was -0.87 [95% confidence interval (CI) –1.07, –0.68]%-units (p 

  • Efficacy and safety of once-weekly glucagon-like peptide 1 receptor agonist Albiglutide (HARMONY 1 trial): 52-week primary endpoint results from a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes mellitus not contro
    Diabetes obesity & metabolism, 2014
    Co-Authors: Jane E.b. Reusch, Murray Stewart, Deborah T Cirkel, Rickey R. Reinhardt, C. M. Perkins, Caroline R Perry, B. W. Bode
    Abstract:

    Aims To show that Albiglutide, a glucagon-like peptide-1 receptor agonist, is an effective and generally safe treatment to improve glycaemic control in patients with type 2 diabetes mellitus whose hyperglycaemia is inadequately controlled with pioglitazone (with or without metformin). Methods In this 3-year, randomized, double-blind, placebo-controlled study, 310 adult patients on a regimen of pioglitazone (with or without metformin) were randomly assigned to receive additional treatment with Albiglutide [30 mg subcutaneous (s.c.) once weekly, n = 155] or matching placebo (n = 155). The primary efficacy endpoint was change from baseline to week 52 (intention-to-treat) in glycated haemoglobin (HbA1c). Results The model-adjusted change from baseline in HbA1c at week 52 was significantly better with Albiglutide than with placebo (−0.8%, 95% confidence interval −1.0, −0.6; p < 0.0001). Change from baseline fasting plasma glucose was −1.3 mmol/l in the Albiglutide group and +0.4 mmol/l in the placebo group (p < 0.0001); a significantly higher percentage of patients reached the HbA1c goals with Albiglutide (p < 0.0001), and the rate of hyperglycaemia rescue up to week 52 for Albiglutide was 24.4 versus 47.7% for placebo (p < 0.0001). Albiglutide plus pioglitazone had no impact on weight, and severe hypoglycaemia was observed rarely (n = 2). With few exceptions, the results of safety assessments were similar between the groups, and most adverse events (AEs) were mild or moderate. The 52-week incidence rates for gastrointestinal AEs for Albiglutide and placebo were: 31.3 and 29.8%, respectively (diarrhoea: 11.3 and 8.6%; nausea: 10.7 and 11.3%; vomiting: 4.0 and 4.0%). Conclusions Albiglutide 30 mg administered once weekly as an add-on to pioglitazone (with or without metformin) provided effective and durable glucose lowering and was generally well tolerated.

  • harmony 4 randomised clinical trial comparing once weekly Albiglutide and insulin glargine in patients with type 2 diabetes inadequately controlled with metformin with or without sulfonylurea
    Diabetologia, 2014
    Co-Authors: Peter N. Weissman, Murray Stewart, Deborah T Cirkel, Caroline Perry, Molly C Carr, Richard E. Pratley
    Abstract:

    Aims/hypothesis The aim of this study was to compare the efficacy and safety of once-weekly Albiglutide with once-daily insulin glargine (A21Gly,B31Arg,B32Arg human insulin) in patients with type 2 diabetes inadequately controlled on metformin with or without sulfonylurea.

Molly C Carr - One of the best experts on this subject based on the ideXlab platform.

  • Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial
    2020
    Co-Authors: Julio Rosenstock, Molly C Carr, Antonio Nino, Joseph Soffer, Lois Erskine, Andre Acusta, Jo Dole, Jason Mallory, Philip Home
    Abstract:

    <b>Objective: </b>The principle of replacing prandial insulin lispro with a once-weekly GLP-1 receptor agonist (GLP-1RA) in type 2 diabetes inadequately controlled on a multiple daily insulin injections regimen was tested with Albiglutide. <p> </p> <p><b>Research Design and Methods</b>: In this treat-to-target study, basal+prandial insulin was optimized over 4 weeks before participants were randomized (1:1) to Albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50% at randomization; subsequently lispro injections were fully discontinued 4 weeks later) (n=402), or to continued optimized lispro plus optimized glargine (n=412).</p> <p> </p> <p><b>Results<a>:</a></b> <a>Mean±SD HbA<sub>1c</sub> at baseline, 7.8±0.6% (61±7 mmol/mol) in the Albiglutide+glargine group and 7.7±0.6% (60±7 mmol/mol) in the lispro+glargine group, were reduced at week 26 to 6.7±0.8% (49±8 mmol/mol) and 6.6±0.8% (48±8 mmol/mol); respectively (LS difference 0.06% [95% CI, −0.05 to 0.17]; noninferiority <i>P</i><0.0001)</a>. In the Albiglutide+glargine group, 218 participants (54%) replaced all prandial insulin without reintroducing lispro up to week 26. Total daily prandial insulin dose was similar at baseline but was lower by 62U/day (95% CI −65.9 to −57.8; <i>P</i><0.0001) at week 26 in the Albiglutide+glargine group <a></a> and the total number of weekly injections was also reduced from 29 to 13 per week. Less severe/documented symptomatic hypoglycemia (57.2% vs. 75.0%) occurred in the Albiglutide+glargine group with meaningful weight differences (LS mean±SE: −2.0±0.2 vs. +2.4±0.2 kg; <i>P</i><0.0001) vs. lispro+glargine. Gastrointestinal adverse events were higher with Albiglutide+glargine (26% vs. 13%). </p> <p> </p> <p><b>Conclusions<a>:</a></b> A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal+prandial insulin treatments and achieve better outcomes in type 2 diabetes. </p>

  • Impact of a Weekly GLP-1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial
    2020
    Co-Authors: Julio Rosenstock, Molly C Carr, Antonio Nino, Joseph Soffer, Lois Erskine, Andre Acusta, Jo Dole, Jason Mallory, Philip Home
    Abstract:

    <b>Objective: </b>The principle of replacing prandial insulin lispro with a once-weekly GLP-1 receptor agonist (GLP-1RA) in type 2 diabetes inadequately controlled on a multiple daily insulin injections regimen was tested with Albiglutide. <p> </p> <p><b>Research Design and Methods</b>: In this treat-to-target study, basal+prandial insulin was optimized over 4 weeks before participants were randomized (1:1) to Albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50% at randomization; subsequently lispro injections were fully discontinued 4 weeks later) (n=402), or to continued optimized lispro plus optimized glargine (n=412).</p> <p> </p> <p><b>Results<a>:</a></b> <a>Mean±SD HbA<sub>1c</sub> at baseline, 7.8±0.6% (61±7 mmol/mol) in the Albiglutide+glargine group and 7.7±0.6% (60±7 mmol/mol) in the lispro+glargine group, were reduced at week 26 to 6.7±0.8% (49±8 mmol/mol) and 6.6±0.8% (48±8 mmol/mol); respectively (LS difference 0.06% [95% CI, −0.05 to 0.17]; noninferiority <i>P</i><0.0001)</a>. In the Albiglutide+glargine group, 218 participants (54%) replaced all prandial insulin without reintroducing lispro up to week 26. Total daily prandial insulin dose was similar at baseline but was lower by 62U/day (95% CI −65.9 to −57.8; <i>P</i><0.0001) at week 26 in the Albiglutide+glargine group <a></a> and the total number of weekly injections was also reduced from 29 to 13 per week. Less severe/documented symptomatic hypoglycemia (57.2% vs. 75.0%) occurred in the Albiglutide+glargine group with meaningful weight differences (LS mean±SE: −2.0±0.2 vs. +2.4±0.2 kg; <i>P</i><0.0001) vs. lispro+glargine. Gastrointestinal adverse events were higher with Albiglutide+glargine (26% vs. 13%). </p> <p> </p> <p><b>Conclusions<a>:</a></b> A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal+prandial insulin treatments and achieve better outcomes in type 2 diabetes. </p>

  • Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial.
    Diabetes care, 2020
    Co-Authors: Julio Rosenstock, Jason M. Mallory, Molly C Carr, Antonio Nino, Joseph Soffer, Andre Acusta, Lois M. Erskine, Jo F. Dole, Philip Home
    Abstract:

    OBJECTIVE The principle of replacing prandial insulin lispro with a once-weekly glucagon-like peptide 1 receptor agonist (GLP-1RA) for type 2 diabetes inadequately controlled on a multiple daily insulin injections regimen was tested with Albiglutide. RESEARCH DESIGN AND METHODS In this treat-to-target study, basal plus prandial insulin was optimized over 4 weeks before participants were randomized (1:1) to Albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50% at randomization; subsequently, lispro injections were fully discontinued 4 weeks later) (n = 402) or to continued optimized lispro plus optimized glargine (n = 412). RESULTS Mean ± SD HbA1c at baseline, 7.8 ± 0.6% (61 ± 7 mmol/mol) in the Albiglutide + glargine group and 7.7 ± 0.6% (60 ± 7 mmol/mol) in the lispro + glargine group, was reduced at week 26 to 6.7% ± 0.8% (49 ± 8 mmol/mol) and 6.6 ± 0.8% (48 ± 8 mmol/mol), respectively (least squares [LS] difference 0.06% [95% CI −0.05 to 0.17]; noninferiority P CONCLUSIONS A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP-1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal plus prandial insulin treatments and achieve better outcomes in type 2 diabetes.

  • weekly glucagon like peptide 1 receptor agonist Albiglutide as monotherapy improves glycemic parameters in japanese patients with type 2 diabetes mellitus a randomized double blind placebo controlled study
    Journal of Diabetes Investigation, 2018
    Co-Authors: Antonio Nino, Timothy Wilson, Molly C Carr, Inaha Okuda, Lynn Yue, Hiromu Nakajima, Maho Tsuboi, Yutaka Seino
    Abstract:

    Aims/Introduction The present phase 3, randomized, double-blind 24-week study with extension to 1 year assessed the efficacy and safety of Albiglutide compared with placebo in Japanese patients with type 2 diabetes mellitus inadequately controlled by diet and exercise with or without a single oral antidiabetic drug. Materials and Methods Patients received weekly Albiglutide 30 mg (n = 160), Albiglutide 50 mg (n = 150) or a placebo switched to Albiglutide 30 mg after 24 weeks (n = 77). Open-label daily liraglutide 0.9 mg (n = 103) was included as a reference. Oral antidiabetic drug use was discontinued before baseline. The primary end-point was 24-week change from baseline in glycated hemoglobin (HbA1c). Secondary end-points included fasting plasma glucose, bodyweight and adverse events. Results At 24 weeks, mean HbA1c changes from baseline were −1.10, −1.30, and 0.25% for Albiglutide 30, 50 mg and placebo, respectively (P vs placebo <0.0001 for both Albiglutide doses), −1.19% for liraglutide. Decreases in HbA1c with Albiglutide were sustained through the study. Mean fasting plasma glucose decreased by ≥20 mg/dL, and the mean change in bodyweight was ≤0.5 kg through 1 year across groups. Most commonly reported adverse events were nasopharyngitis, constipation and nausea. The incidence of adverse events was higher in active treatment groups than in the placebo group. Few hypoglycemia events were reported; no patient withdrew as a result of hypoglycemia. No new safety signals were detected. Conclusions Albiglutide monotherapy achieved clinically significant decreases in HbA1c and fasting plasma glucose with good tolerability in Japanese patients with type 2 diabetes mellitus inadequately controlled by diet and exercise with or without a single oral antidiabetic drug.

  • Weekly glucagon-like peptide-1 receptor agonist Albiglutide as monotherapy improves glycemic parameters in Japanese patients with type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled study.
    Journal of diabetes investigation, 2017
    Co-Authors: Antonio Nino, Timothy Wilson, Molly C Carr, Inaha Okuda, Lynn Yue, Hiromu Nakajima, Maho Tsuboi, Yutaka Seino
    Abstract:

    Aims/Introduction The present phase 3, randomized, double-blind 24-week study with extension to 1 year assessed the efficacy and safety of Albiglutide compared with placebo in Japanese patients with type 2 diabetes mellitus inadequately controlled by diet and exercise with or without a single oral antidiabetic drug. Materials and Methods Patients received weekly Albiglutide 30 mg (n = 160), Albiglutide 50 mg (n = 150) or a placebo switched to Albiglutide 30 mg after 24 weeks (n = 77). Open-label daily liraglutide 0.9 mg (n = 103) was included as a reference. Oral antidiabetic drug use was discontinued before baseline. The primary end-point was 24-week change from baseline in glycated hemoglobin (HbA1c). Secondary end-points included fasting plasma glucose, bodyweight and adverse events. Results At 24 weeks, mean HbA1c changes from baseline were −1.10, −1.30, and 0.25% for Albiglutide 30, 50 mg and placebo, respectively (P vs placebo

Bo Ahrén - One of the best experts on this subject based on the ideXlab platform.

  • Three-year data from 5 HARMONY phase 3 clinical trials of Albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy
    Diabetes research and clinical practice, 2017
    Co-Authors: Philip Home, Bo Ahrén, Deborah T Cirkel, Molly C Carr, Jane E.b. Reusch, Marc Rendell, Peter N. Weissman, Diane Miller, Philip D. Ambery, Michael A. Nauck
    Abstract:

    Abstract Aims Diabetes therapies that provide durable glycaemic control for people with type 2 diabetes mellitus (T2DM) are needed. We present efficacy results of Albiglutide, a glucagon-like peptide-1 receptor agonist, in people with T2DM over a 3-year period. Methods Five of the 8 HARMONY phase 3 trials, comparing Albiglutide with other therapies or placebo across a spectrum of clinical care, lasted for a preplanned 3 years. Participants with uncontrolled hyperglycaemia who met predetermined criteria could receive rescue medication. The ability to remain on study medication without needing additional rescue was an efficacy measure. Glycaemic measures and body weight were analysed in 2 populations: those who remained rescue-free and all participants. Results Participants ( n  = 3132) were randomised to Albiglutide or comparator. A greater proportion of participants who received Albiglutide remained rescue-free (55–71%) compared with placebo (35–51%; p p  = 0.002). The proportion of rescue-free participants with Albiglutide did not differ from glimepiride or insulin glargine, was higher than with sitagliptin ( p  = 0.013), and lower than with pioglitazone ( p  = 0.045). At 3 years, Albiglutide was associated with clinically significant reductions in hyperglycaemia (eg, rescue-free participants: HbA1c −0.52% [SE0.11] to −0.98% [0.12]; −5.7 mmol/mol [1.2] to −10.7 mmol/mol [1.3] and all participants: HbA1c −0.29% [0.11] to − 0.92% [0.13]; −3.2 mmol/mol [1.2] to −10.1 mmol/mol [1.4]). Albiglutide was also associated with modest reductions in body weight vs pioglitazone, glimepiride, and insulin glargine, which were associated with weight gain. Conclusion These 3-year efficacy data support long-term use of Albiglutide in the management of people with T2DM. ClinicalTrials.gov NCT00849056 , NCT00849017 , NCT00838903 , NCT00838916 , NCT00839527 .

  • Once weekly glucagon-like peptide-1 receptor agonist Albiglutide vs. prandial insulin added to basal insulin in patients with type 2 diabetes mellitus: Results over 52 weeks
    Journal of diabetes and its complications, 2017
    Co-Authors: Lawrence A. Leiter, Susan L Johnson, Diane Miller, Jorge Luiz Gross, Francis C.c. Chow, Bo Ahrén
    Abstract:

    We have previously reported that once-weekly Albiglutide was noninferior to thrice-daily lispro for glycemic lowering, with decreased weight and risk of hypoglycemia, in patients inadequately controlled on basal insulin over 26 weeks. Findings after 52 weeks reveal similar responses to Albiglutide as an add-on to insulin glargine.

  • Albiglutide for the treatment of type 2 diabetes mellitus: An integrated safety analysis of the HARMONY phase 3 trials
    Diabetes research and clinical practice, 2017
    Co-Authors: Bo Ahrén, Jason M. Mallory, Timothy Wilson, Molly C Carr, Karen Murphy, Christopher Perkins, Marc Rendell, Susan L Johnson
    Abstract:

    Aims Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) stimulate the incretin system and lower glycaemic parameters in type 2 diabetes mellitus (T2DM). This analysis of clinical studies of up to 3 years evaluated the safety of Albiglutide, a GLP-1 RA, in people with T2DM. Methods Integrated safety analysis included seven phase-3 T2DM studies of Albiglutide compared with placebo and/or active comparators (a dipeptidyl peptidase-4 inhibitor, GLP-1 RA, insulin, sulphonylurea, and thiazolidinedione). Results Studies of 32 months (HARMONY 7), 1 year (HARMONY 6), and 3 years (HARMONY 1–5), reported similar rates of adverse events (AEs) (84.8%, 82.3%), and serious AEs (13.1%, 12.9%) between Albiglutide and all comparators, respectively. AEs that did not differ between the groups included symptomatic or severe hypoglycaemia as well as nausea (12.0%, 11.3%) and vomiting (5.3%, 4.7%) for Albiglutide and all comparators, respectively. According to the Medical Dictionary for Regulatory Activities preferred terms, only diarrhoea (13.7%, 9.9%), injection-site reaction (9.0%, 2.0%), and peripheral oedema (4.5%, 6.8%) had at least 2% difference between the Albiglutide and all-comparator groups. In a similar integrated analysis, pancreatitis occurred more often with Albiglutide (0.3%, 0.1%). Renal and cardiac function did not differ between the two groups. Conclusions In an integrated analysis of seven phase 3 clinical trials, Albiglutide-treated patients experienced frequencies of AEs (including cardiovascular and renal) similar to the all-comparators group treated with other T2DM medications or placebo. Albiglutide treatment was associated with higher rates of diarrhoea and injection-site reactions, but not increased nausea and vomiting, versus all comparators.

  • advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents a comparison of adding Albiglutide a weekly glp 1 receptor agonist versus thrice daily prandial insulin lispro
    Diabetes Care, 2014
    Co-Authors: Julio Rosenstock, Bo Ahrén, Susan L Johnson, Fred Yang, Diane Miller, Jorge Luiz Gross, Francis C.c. Chow, Vivian Fonseca, Robert E Ratner, Murray Stewart
    Abstract:

    OBJECTIVE GLP-1 receptor agonists may provide an alternative to prandial insulin for advancing basal insulin therapy. Harmony 6 was a randomized, open-label, active-controlled trial testing once-weekly Albiglutide vs thrice-daily prandial insulin lispro as an add-on to titrated once-daily insulin glargine. RESEARCH DESIGN AND METHODS Patients taking basal insulin (with or without oral agents) with HbA 1c 7–10.5% (53–91 mmol/mol) entered a glargine standardization period, followed by randomization to Albiglutide, 30 mg weekly ( n = 282), subsequently uptitrated to 50 mg, if necessary, or thrice-daily prandial lispro ( n = 281) while continuing metformin and/or pioglitazone. Glargine was titrated to fasting plasma glucose of 1c change from baseline at week 26. RESULTS At week 26, HbA 1c decreased from baseline by −0.82 ± SE 0.06% (9.0 mmol/mol) with Albiglutide and −0.66 ± 0.06% (7.2 mmol/mol) with lispro; treatment difference, −0.16% (95% CI −0.32 to 0.00; 1.8 mmol/mol; P CONCLUSIONS Weekly Albiglutide is a simpler therapeutic option than thrice-daily lispro for advancing basal insulin glargine therapy, resulting in comparable HbA 1c reduction with weight loss and lower hypoglycemia risk.

  • harmony 3 104 week randomized double blind placebo and active controlled trial assessing the efficacy and safety of Albiglutide compared with placebo sitagliptin and glimepiride in patients with type 2 diabetes taking metformin
    Diabetes Care, 2014
    Co-Authors: Bo Ahrén, Susan L Johnson, Murray Stewart, Deborah T Cirkel, Fred Yang, Caroline Perry, Mark N Feinglos
    Abstract:

    OBJECTIVE To compare the efficacy and safety of weekly Albiglutide with daily sitagliptin, daily glimepiride, and placebo. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes receiving metformin were randomized to Albiglutide (30 mg), sitagliptin (100 mg), glimepiride (2 mg), or placebo. Blinded dose titration for Albiglutide (to 50 mg) and glimepiride (to 4 mg) was based on predefined hyperglycemia criteria. The primary end point was change in HbA 1c from baseline at week 104. Secondary end points included fasting plasma glucose (FPG), weight, and time to hyperglycemic rescue. RESULTS Baseline characteristics were similar among the Albiglutide ( n = 302), glimepiride ( n = 307), sitagliptin ( n = 302), and placebo ( n = 101) groups. Baseline HbA 1c was 8.1% (65.0 mmol/mol); mean age was 54.5 years. The mean doses for Albiglutide and glimepiride at week 104 were 40.5 and 3.1 mg, respectively. At week 104, Albiglutide significantly reduced HbA 1c compared with placebo (−0.9% [−9.8 mmol/mol]; P P = 0.0001), and glimepiride (−0.3% [−3.3 mmol/mol]; P = 0.0033). Outcomes for FPG and HbA 1c were similar. Weight change from baseline for each were as follows: Albiglutide −1.21 kg (95% CI −1.68 to −0.74), placebo −1.00 kg (95% CI −1.81 to −0.20), sitagliptin −0.86 kg (95% CI −1.32 to −0.39), glimepiride 1.17 kg (95% CI 0.70–1.63). The difference between Albiglutide and glimepiride was statistically significant ( P P P = 0.0118), and 32.7% ( P = 0.1504) for placebo, sitagliptin, and glimepiride, respectively. Rates of serious adverse events in the Albiglutide group were similar to comparison groups. Diarrhea (Albiglutide 12.9%, other groups 8.6–10.9%) and nausea (Albiglutide 10.3%, other groups 6.2–10.9%) were generally the most frequently reported gastrointestinal events. CONCLUSION Added to metformin, Albiglutide was well-tolerated; produced superior reductions in HbA 1c and FPG at week 104 compared with placebo, sitagliptin, and glimepiride; and resulted in weight loss compared with glimepiride.

Antonio Nino - One of the best experts on this subject based on the ideXlab platform.

  • Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial
    2020
    Co-Authors: Julio Rosenstock, Molly C Carr, Antonio Nino, Joseph Soffer, Lois Erskine, Andre Acusta, Jo Dole, Jason Mallory, Philip Home
    Abstract:

    <b>Objective: </b>The principle of replacing prandial insulin lispro with a once-weekly GLP-1 receptor agonist (GLP-1RA) in type 2 diabetes inadequately controlled on a multiple daily insulin injections regimen was tested with Albiglutide. <p> </p> <p><b>Research Design and Methods</b>: In this treat-to-target study, basal+prandial insulin was optimized over 4 weeks before participants were randomized (1:1) to Albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50% at randomization; subsequently lispro injections were fully discontinued 4 weeks later) (n=402), or to continued optimized lispro plus optimized glargine (n=412).</p> <p> </p> <p><b>Results<a>:</a></b> <a>Mean±SD HbA<sub>1c</sub> at baseline, 7.8±0.6% (61±7 mmol/mol) in the Albiglutide+glargine group and 7.7±0.6% (60±7 mmol/mol) in the lispro+glargine group, were reduced at week 26 to 6.7±0.8% (49±8 mmol/mol) and 6.6±0.8% (48±8 mmol/mol); respectively (LS difference 0.06% [95% CI, −0.05 to 0.17]; noninferiority <i>P</i><0.0001)</a>. In the Albiglutide+glargine group, 218 participants (54%) replaced all prandial insulin without reintroducing lispro up to week 26. Total daily prandial insulin dose was similar at baseline but was lower by 62U/day (95% CI −65.9 to −57.8; <i>P</i><0.0001) at week 26 in the Albiglutide+glargine group <a></a> and the total number of weekly injections was also reduced from 29 to 13 per week. Less severe/documented symptomatic hypoglycemia (57.2% vs. 75.0%) occurred in the Albiglutide+glargine group with meaningful weight differences (LS mean±SE: −2.0±0.2 vs. +2.4±0.2 kg; <i>P</i><0.0001) vs. lispro+glargine. Gastrointestinal adverse events were higher with Albiglutide+glargine (26% vs. 13%). </p> <p> </p> <p><b>Conclusions<a>:</a></b> A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal+prandial insulin treatments and achieve better outcomes in type 2 diabetes. </p>

  • Impact of a Weekly GLP-1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial
    2020
    Co-Authors: Julio Rosenstock, Molly C Carr, Antonio Nino, Joseph Soffer, Lois Erskine, Andre Acusta, Jo Dole, Jason Mallory, Philip Home
    Abstract:

    <b>Objective: </b>The principle of replacing prandial insulin lispro with a once-weekly GLP-1 receptor agonist (GLP-1RA) in type 2 diabetes inadequately controlled on a multiple daily insulin injections regimen was tested with Albiglutide. <p> </p> <p><b>Research Design and Methods</b>: In this treat-to-target study, basal+prandial insulin was optimized over 4 weeks before participants were randomized (1:1) to Albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50% at randomization; subsequently lispro injections were fully discontinued 4 weeks later) (n=402), or to continued optimized lispro plus optimized glargine (n=412).</p> <p> </p> <p><b>Results<a>:</a></b> <a>Mean±SD HbA<sub>1c</sub> at baseline, 7.8±0.6% (61±7 mmol/mol) in the Albiglutide+glargine group and 7.7±0.6% (60±7 mmol/mol) in the lispro+glargine group, were reduced at week 26 to 6.7±0.8% (49±8 mmol/mol) and 6.6±0.8% (48±8 mmol/mol); respectively (LS difference 0.06% [95% CI, −0.05 to 0.17]; noninferiority <i>P</i><0.0001)</a>. In the Albiglutide+glargine group, 218 participants (54%) replaced all prandial insulin without reintroducing lispro up to week 26. Total daily prandial insulin dose was similar at baseline but was lower by 62U/day (95% CI −65.9 to −57.8; <i>P</i><0.0001) at week 26 in the Albiglutide+glargine group <a></a> and the total number of weekly injections was also reduced from 29 to 13 per week. Less severe/documented symptomatic hypoglycemia (57.2% vs. 75.0%) occurred in the Albiglutide+glargine group with meaningful weight differences (LS mean±SE: −2.0±0.2 vs. +2.4±0.2 kg; <i>P</i><0.0001) vs. lispro+glargine. Gastrointestinal adverse events were higher with Albiglutide+glargine (26% vs. 13%). </p> <p> </p> <p><b>Conclusions<a>:</a></b> A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal+prandial insulin treatments and achieve better outcomes in type 2 diabetes. </p>

  • Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial.
    Diabetes care, 2020
    Co-Authors: Julio Rosenstock, Jason M. Mallory, Molly C Carr, Antonio Nino, Joseph Soffer, Andre Acusta, Lois M. Erskine, Jo F. Dole, Philip Home
    Abstract:

    OBJECTIVE The principle of replacing prandial insulin lispro with a once-weekly glucagon-like peptide 1 receptor agonist (GLP-1RA) for type 2 diabetes inadequately controlled on a multiple daily insulin injections regimen was tested with Albiglutide. RESEARCH DESIGN AND METHODS In this treat-to-target study, basal plus prandial insulin was optimized over 4 weeks before participants were randomized (1:1) to Albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50% at randomization; subsequently, lispro injections were fully discontinued 4 weeks later) (n = 402) or to continued optimized lispro plus optimized glargine (n = 412). RESULTS Mean ± SD HbA1c at baseline, 7.8 ± 0.6% (61 ± 7 mmol/mol) in the Albiglutide + glargine group and 7.7 ± 0.6% (60 ± 7 mmol/mol) in the lispro + glargine group, was reduced at week 26 to 6.7% ± 0.8% (49 ± 8 mmol/mol) and 6.6 ± 0.8% (48 ± 8 mmol/mol), respectively (least squares [LS] difference 0.06% [95% CI −0.05 to 0.17]; noninferiority P CONCLUSIONS A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP-1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal plus prandial insulin treatments and achieve better outcomes in type 2 diabetes.

  • Efficacy and safety of an Albiglutide liquid formulation compared with the lyophilized formulation: A 26-week randomized, double-blind, repeat-dose study in patients with type 2 diabetes mellitus.
    Diabetes research and clinical practice, 2019
    Co-Authors: Bonnie C. Shaddinger, Joseph Soffer, Georgios Vlasakakis, Mayadah Shabbout, Cynthia B. Weston, Antonio Nino
    Abstract:

    Abstract Aims Compare the efficacy and safety of Albiglutide from a ready-to-use, single-dose, auto-injector system with the lyophilized product in patients with type 2 diabetes mellitus (T2DM). Methods In this phase 3 study, 308 patients between 18 and 80 years with T2DM and experiencing inadequate glycemic control on their current regimen of diet/exercise alone or in combination with metformin were randomized 1:1 to weekly injections for 26 weeks with an active Albiglutide auto-injector and placebo lyophilized dual-chamber cartridge (DCC) pen injector (n = 154) or active Albiglutide lyophilized DCC pen injector and placebo liquid auto-injector (n = 154). Participants received liquid or lyophilized Albiglutide 30 mg for 4 weeks, and then 50 mg for the remaining 22 weeks. Change in HbA1c and fasting plasma glucose (FPG), pharmacokinetics, and safety were assessed. Results In the Albiglutide liquid and lyophilized drug product groups, 55.6% (85/153) and 45.5% of patients (70/154) had a baseline HbA1c ≥ 8.0%, respectively. The model-adjusted least squares (LS) mean change in HbA1c from baseline at week 26 was −1.1% (95% CI: −1.3, −1.0) and −1.2% (95% CI: −1.3, −1.0; noninferiority P = 0.0002) in the Albiglutide liquid and lyophilized product groups, respectively. Similarly, the model-adjusted LS mean change in FPG from baseline at week 26 in the Albiglutide liquid and lyophilized product groups was −2.2 (95% CI: −2.6, −1.8) mmol/L and −1.9 (95% CI: −2.3, −1.5) mmol/L, respectively. No new safety concerns were identified. Conclusion Change from baseline in HbA1c for Albiglutide liquid was noninferior to lyophilized drug product in patients with T2DM.

  • A Randomized, Double-Blind, Single-Dose, Crossover Study to Demonstrate the Bioequivalence of 2 Formulations of Albiglutide in Healthy Adult Participants.
    Clinical pharmacology in drug development, 2018
    Co-Authors: Bonnie C. Shaddinger, Joseph Soffer, Georgios Vlasakakis, Karl M. Thorpe, Daniel Hatch, Antonio Nino
    Abstract:

    Albiglutide, developed for treatment of type 2 diabetes mellitus, is provided in a dual-chamber cartridge (DCC) single-dose pen-injector containing lyophilized drug that must be reconstituted with diluent prior to use. A liquid formulation of Albiglutide has been developed that does not require mixing. In this 2-period, randomized, crossover, double-blind, phase I study (NCT02660736) in 59 healthy volunteers, pharmacokinetic parameters were determined and the bioequivalence of the 2 formulations was assessed. Participants received injections from each type of pen-injector, one containing Albiglutide 50 mg and one containing placebo, followed by an 8-week washout period between regimens: Albiglutide 50-mg liquid formulation from an auto-injector and lyophilized placebo from a DCC pen-injector (Regimen A), or placebo liquid from an auto-injector and lyophilized Albiglutide 50 mg from a DCC pen-injector (Regimen B). Geometric mean total exposures (area under the drug concentration-time curve [AUC](0-t) [1345.4 vs 1426.9 (μg · h/mL)], AUC(0-∞) [1376.2 vs 1454.6 (μg · h/mL)], and maximum concentration of drug in blood plasma [4968.5 vs 5314.7 ng/mL]) were comparable between Regimens A and B. Ratios of geometric least square means (90% confidence interval) were 95.3% (89.49-101.52) for AUC(0-∞) , 95.1% (89.12-101.49) for AUC(0-t) , and 93.2% (86.76-100.17) for maximum concentration of drug in blood plasma, falling within the 90% confidence interval of 0.80 to 1.25 for bioequivalence. No new safety concerns were observed.

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  • PANCREATIC SAFETY IN STUDIES OF THE GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONIST Albiglutide.
    Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, 2019
    Co-Authors: Firas Al-kawas, Susan L Johnson, Timothy Wilson, Michelle Ann Anderson, Robert Enns, Jason M. Mallory
    Abstract:

    Objective: Albiglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), reduces glycated hemoglobin with a low risk of hypoglycemia in patients with type 2 diabetes. The relationship between GLP-1RAs and risk of pancreatitis is unresolved. This independent, rigorous, expert review of the Albiglutide HARMONY Phase III clinical program examined suspected cases of acute pancreatitis. Methods: An independent pancreatitis adjudication committee (PAC), composed of physicians with expertise in gastroenterology and pancreatic disease, was prospectively established to review cases of suspected acute pancreatitis in the HARMONY studies. Results: Patients treated in Phase III trials with Albiglutide (n = 2,365), or active or placebo comparators (n = 2,530), averaged 56 years of age with a mean 8.3-year diabetes duration. Across the 8 studies, the PAC reviewed potential cases of treatment-emergent acute pancreatitis in 43 patients. Definite or probable acute pancreatitis was adjudicated for 11 patients (8 Albiglutide; 3 active comparators). Most of these were considered by the PAC to be at least possibly related to study treatment (6 of 8 Albiglutide cases and 2 of 3 active comparator cases). Both cases in the active comparator group adjudicated as definite or probable pancreatitis with at least a possible relationship to study treatment were in patients treated with a GLP-1RA. The frequency of pancreatitis was higher among patients treated with Albiglutide (6/2,365, 0.3%) than with placebo (0/486, 0%) or active comparators (2/2,062, 0.08%). Conclusion: In the HARMONY Phase III program, adjudicated cases of acute pancreatitis were uncommon. However, within the limitations of available data, the incidence of acute pancreatitis with Albiglutide appears to be within the range described for other studies of GLP-1RAs. Abbreviations: AE = adverse event; CI = confidence interval; DPP-4 = dipeptidyl peptidase-4; GLP-1 = glucagon-like peptide-1; GLP-1RA = glucagon-like peptide-1 receptor agonist; MH-OR = Mantel-Haenszel odds ratio; OR = odds ratio; PAC = pancreatitis adjudication committee; SAE = serious adverse event; ULN = upper limit of normal.

  • Once weekly glucagon-like peptide-1 receptor agonist Albiglutide vs. prandial insulin added to basal insulin in patients with type 2 diabetes mellitus: Results over 52 weeks
    Journal of diabetes and its complications, 2017
    Co-Authors: Lawrence A. Leiter, Susan L Johnson, Diane Miller, Jorge Luiz Gross, Francis C.c. Chow, Bo Ahrén
    Abstract:

    We have previously reported that once-weekly Albiglutide was noninferior to thrice-daily lispro for glycemic lowering, with decreased weight and risk of hypoglycemia, in patients inadequately controlled on basal insulin over 26 weeks. Findings after 52 weeks reveal similar responses to Albiglutide as an add-on to insulin glargine.

  • Albiglutide for the treatment of type 2 diabetes mellitus: An integrated safety analysis of the HARMONY phase 3 trials
    Diabetes research and clinical practice, 2017
    Co-Authors: Bo Ahrén, Jason M. Mallory, Timothy Wilson, Molly C Carr, Karen Murphy, Christopher Perkins, Marc Rendell, Susan L Johnson
    Abstract:

    Aims Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) stimulate the incretin system and lower glycaemic parameters in type 2 diabetes mellitus (T2DM). This analysis of clinical studies of up to 3 years evaluated the safety of Albiglutide, a GLP-1 RA, in people with T2DM. Methods Integrated safety analysis included seven phase-3 T2DM studies of Albiglutide compared with placebo and/or active comparators (a dipeptidyl peptidase-4 inhibitor, GLP-1 RA, insulin, sulphonylurea, and thiazolidinedione). Results Studies of 32 months (HARMONY 7), 1 year (HARMONY 6), and 3 years (HARMONY 1–5), reported similar rates of adverse events (AEs) (84.8%, 82.3%), and serious AEs (13.1%, 12.9%) between Albiglutide and all comparators, respectively. AEs that did not differ between the groups included symptomatic or severe hypoglycaemia as well as nausea (12.0%, 11.3%) and vomiting (5.3%, 4.7%) for Albiglutide and all comparators, respectively. According to the Medical Dictionary for Regulatory Activities preferred terms, only diarrhoea (13.7%, 9.9%), injection-site reaction (9.0%, 2.0%), and peripheral oedema (4.5%, 6.8%) had at least 2% difference between the Albiglutide and all-comparator groups. In a similar integrated analysis, pancreatitis occurred more often with Albiglutide (0.3%, 0.1%). Renal and cardiac function did not differ between the two groups. Conclusions In an integrated analysis of seven phase 3 clinical trials, Albiglutide-treated patients experienced frequencies of AEs (including cardiovascular and renal) similar to the all-comparators group treated with other T2DM medications or placebo. Albiglutide treatment was associated with higher rates of diarrhoea and injection-site reactions, but not increased nausea and vomiting, versus all comparators.

  • advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents a comparison of adding Albiglutide a weekly glp 1 receptor agonist versus thrice daily prandial insulin lispro
    Diabetes Care, 2014
    Co-Authors: Julio Rosenstock, Bo Ahrén, Susan L Johnson, Fred Yang, Diane Miller, Jorge Luiz Gross, Francis C.c. Chow, Vivian Fonseca, Robert E Ratner, Murray Stewart
    Abstract:

    OBJECTIVE GLP-1 receptor agonists may provide an alternative to prandial insulin for advancing basal insulin therapy. Harmony 6 was a randomized, open-label, active-controlled trial testing once-weekly Albiglutide vs thrice-daily prandial insulin lispro as an add-on to titrated once-daily insulin glargine. RESEARCH DESIGN AND METHODS Patients taking basal insulin (with or without oral agents) with HbA 1c 7–10.5% (53–91 mmol/mol) entered a glargine standardization period, followed by randomization to Albiglutide, 30 mg weekly ( n = 282), subsequently uptitrated to 50 mg, if necessary, or thrice-daily prandial lispro ( n = 281) while continuing metformin and/or pioglitazone. Glargine was titrated to fasting plasma glucose of 1c change from baseline at week 26. RESULTS At week 26, HbA 1c decreased from baseline by −0.82 ± SE 0.06% (9.0 mmol/mol) with Albiglutide and −0.66 ± 0.06% (7.2 mmol/mol) with lispro; treatment difference, −0.16% (95% CI −0.32 to 0.00; 1.8 mmol/mol; P CONCLUSIONS Weekly Albiglutide is a simpler therapeutic option than thrice-daily lispro for advancing basal insulin glargine therapy, resulting in comparable HbA 1c reduction with weight loss and lower hypoglycemia risk.

  • harmony 3 104 week randomized double blind placebo and active controlled trial assessing the efficacy and safety of Albiglutide compared with placebo sitagliptin and glimepiride in patients with type 2 diabetes taking metformin
    Diabetes Care, 2014
    Co-Authors: Bo Ahrén, Susan L Johnson, Murray Stewart, Deborah T Cirkel, Fred Yang, Caroline Perry, Mark N Feinglos
    Abstract:

    OBJECTIVE To compare the efficacy and safety of weekly Albiglutide with daily sitagliptin, daily glimepiride, and placebo. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes receiving metformin were randomized to Albiglutide (30 mg), sitagliptin (100 mg), glimepiride (2 mg), or placebo. Blinded dose titration for Albiglutide (to 50 mg) and glimepiride (to 4 mg) was based on predefined hyperglycemia criteria. The primary end point was change in HbA 1c from baseline at week 104. Secondary end points included fasting plasma glucose (FPG), weight, and time to hyperglycemic rescue. RESULTS Baseline characteristics were similar among the Albiglutide ( n = 302), glimepiride ( n = 307), sitagliptin ( n = 302), and placebo ( n = 101) groups. Baseline HbA 1c was 8.1% (65.0 mmol/mol); mean age was 54.5 years. The mean doses for Albiglutide and glimepiride at week 104 were 40.5 and 3.1 mg, respectively. At week 104, Albiglutide significantly reduced HbA 1c compared with placebo (−0.9% [−9.8 mmol/mol]; P P = 0.0001), and glimepiride (−0.3% [−3.3 mmol/mol]; P = 0.0033). Outcomes for FPG and HbA 1c were similar. Weight change from baseline for each were as follows: Albiglutide −1.21 kg (95% CI −1.68 to −0.74), placebo −1.00 kg (95% CI −1.81 to −0.20), sitagliptin −0.86 kg (95% CI −1.32 to −0.39), glimepiride 1.17 kg (95% CI 0.70–1.63). The difference between Albiglutide and glimepiride was statistically significant ( P P P = 0.0118), and 32.7% ( P = 0.1504) for placebo, sitagliptin, and glimepiride, respectively. Rates of serious adverse events in the Albiglutide group were similar to comparison groups. Diarrhea (Albiglutide 12.9%, other groups 8.6–10.9%) and nausea (Albiglutide 10.3%, other groups 6.2–10.9%) were generally the most frequently reported gastrointestinal events. CONCLUSION Added to metformin, Albiglutide was well-tolerated; produced superior reductions in HbA 1c and FPG at week 104 compared with placebo, sitagliptin, and glimepiride; and resulted in weight loss compared with glimepiride.