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GETGOAL-X
A Randomized, Open-label, Active-controlled, 2-arm Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 Versus Exenatide on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
639
18 countries
18
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide in comparison to exenatide (Byetta®), as an add-on treatment to 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 (%) or HbA1c less than or equal to (\<=) 6.5%, fasting plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper gastrointestinal disorders - quality of life \[PAGI-QOL\]).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2010
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.
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
June 26, 2008
Actual (reported)June 30, 2008
Actual (reported)November 2010
Actual (reported)November 2010
Actual (reported)October 11, 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 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in 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 Fasting Plasma Glucose (FPG) at Week 24
Baseline, Week 24
Change From Baseline in Body Weight at Week 24
Baseline, Week 24
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24
Week 24
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24
Week 24
Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period
Baseline up to Week 24
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24
Baseline, Week 24
Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia
First dose of study drug up to 3 days after the last dose administration, for up to 116 weeks
Quality of Life: Change From Baseline in Patient's Satisfaction to Treatment (PAGI-QOL) 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.
1-step initiation regimen of exenatide: 5 mcg twice daily (BID) for 4 weeks, followed by 10 mcg BID up to the end of treatment.
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
Buenos Aires, Argentina
Sanofi-Aventis Administrative Office
Vienna, Austria
Sanofi-Aventis Administrative Office
São Paulo, Brazil
Sanofi-Aventis Administrative Office
Bogotá, Colombia
Sanofi-Aventis Administrative Office
Hørsholm, Denmark
Sanofi-Aventis Administrative Office
Helsinki, Finland
Rosenstock J, Raccah D, Koranyi L, Maffei L, Boka G, Miossec P, Gerich JE. 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 Oct;36(10):2945-51. doi: 10.2337/dc12-2709. Epub 2013 May 22.
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Clinical Sciences & Operations
Sanofi
639 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2008
First Posted
June 30, 2008
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Self administered by subcutaneous injections twice daily within the hour preceding breakfast and within the hour preceding dinner.
Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.
Contact the study team to confirm eligibility.
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Athens, Greece
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Lysaker, Norway
Sanofi-Aventis Administrative Office
Warsaw, Poland
Sanofi-Aventis Administrative Office
San Juan, Puerto Rico
Sanofi-Aventis Administrative Office
Moscow, Russia
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Bromma, Sweden
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)Last Updated
December 2, 2016
Results First Posted
October 11, 2016
Record last verified: 2016-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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