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GETGOAL-S
A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of a Sulfonylurea in Patients With Type 2 Diabetes Not Adequately Controlled With Sulfonylurea
Sponsor study identifier
Secondary identifiers
interventional
859
16 countries
16
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to sulfonylurea without or with metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to sulfonylurea with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than (\<) 7 percent (%); percentage of patients reaching HbA1c less than or equal to (\<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG), glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a sub-study in all patients in selected centers; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 10, 2008
Actual (reported)July 14, 2008
Actual (reported)January 2011
Actual (reported)January 2011
Actual (reported)December 14, 2016
Actual (reported)Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-Treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Baseline, Week 24
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24
Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline, Week 24
Change From Baseline in Body Weight at Week 24
Baseline, Week 24
Change From Baseline in Beta-cell Function Assessed by HOMA-beta at Week 24
Baseline, Week 24
Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24
Baseline, Week 24
Change From Baseline in Glucose Excursion at Week 24
Baseline, Week 24
Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24
Baseline, Week 24
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24
Baseline, Week 24
2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, United States
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Sanofi-Aventis Administrative Office
Prague, Czechia
Sanofi-Aventis Administrative Office
Cairo, Egypt
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Mumbai, India
Sanofi-Aventis Administrative Office
Netanya, Israel
Rosenstock J, Hanefeld M, Shamanna P, Min KW, Boka G, Miossec P, Zhou T, Muehlen-Bartmer I, Ratner RE. 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). J Diabetes Complications. 2014 May-Jun;28(3):386-92. doi: 10.1016/j.jdiacomp.2014.01.012. Epub 2014 Jan 28.
Ahren B, Galstyan G, Gautier JF, Giorgino F, Gomez-Peralta F, Krebs M, Nikonova E, Stager W, Vargas-Uricoechea H. Postprandial Glucagon Reductions Correlate to Reductions in Postprandial Glucose and Glycated Hemoglobin with Lixisenatide Treatment in Type 2 Diabetes Mellitus: A Post Hoc Analysis. Diabetes Ther. 2016 Sep;7(3):583-90. doi: 10.1007/s13300-016-0179-6. Epub 2016 Jun 18.
Clinical Sciences & Operations
Sanofi
859 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2008
First Posted
July 14, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Sulfonylurea to be continued at maximum effective dose according to local labeling up to end of treatment.
Metformin if given to be continued at stable dose (at least 1.5 gram per day \[except at least 0.75 gram per day in Japan and 1.0 gram per day in South Korea\]) up to the end of treatment.
Contact the study team to confirm eligibility.
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Bucharest, Romania
Sanofi-Aventis Administrative Office
Moscow, Russia
Sanofi-Aventis Administrative Office
Seoul, South Korea
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Sanofi-Aventis Administrative Office
Bangkok, Thailand
Sanofi-Aventis Administrative Office
Mégrine, Tunisia
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)
Yabe D, Ambos A, Cariou B, Duvnjak L, Evans M, Gonzalez-Galvez G, Lin J, Nikonova EV, de Pablos-Velasco P, Yale JF, Ahren B. Efficacy of lixisenatide in patients with type 2 diabetes: A post hoc analysis of patients with diverse beta-cell function in the GetGoal-M and GetGoal-S trials. J Diabetes Complications. 2016 Sep-Oct;30(7):1385-92. doi: 10.1016/j.jdiacomp.2016.05.018. Epub 2016 May 24.
Seino H, Onishi Y, Naito Y, Komatsu M. Lixisenatide improves glycemic outcomes of Japanese patients with type 2 diabetes: a meta-analysis. Diabetol Metab Syndr. 2016 Jun 1;8:36. doi: 10.1186/s13098-016-0151-7. eCollection 2016.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)Last Updated
December 14, 2016
Results First Posted
December 14, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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