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GETGOAL-MONO
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 12-week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents
Sponsor study identifier
Secondary identifiers
interventional
361
12 countries
12
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 12. Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and 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.
December 2009
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.
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 7, 2008
Actual (reported)June 3, 2008
Actual (reported)December 2009
Actual (reported)December 2009
Actual (reported)December 12, 2016
Actual (reported)Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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 12
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12
Baseline, Week 12
Change From Baseline in Body Weight at Week 12
Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Baseline, Week 12
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12
Week 12
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12
Week 12
Change From Baseline in Glucose Excursion at Week 12
Baseline, Week 12
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12
Baseline, Week 12
Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia
First dose of study drug up to 3 days after the last dose administration
2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12.
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
Diegem, Belgium
Sanofi-Aventis Administrative Office
Mumbai, India
Sanofi-Aventis Administrative Office
Netanya, Israel
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sanofi-Aventis Administrative Office
México, Mexico
Sanofi-Aventis Administrative Office
Warsaw, Poland
Fonseca VA, Alvarado-Ruiz R, Raccah D, Boka G, Miossec P, Gerich JE; EFC6018 GetGoal-Mono Study Investigators. 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 Jun;35(6):1225-31. doi: 10.2337/dc11-1935. Epub 2012 Mar 19.
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Clinical Sciences & Operations
Sanofi
361 participants (actual enrollment reported by the registry).
First Submitted
May 7, 2008
First Posted
June 3, 2008
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
2-step initiation regimen of lixisenatide: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12.
Contact the study team to confirm eligibility.
Sanofi-Aventis Administrative Office
Bucharest, Romania
Sanofi-Aventis Administrative Office
Moscow, Russia
Sanofi-Aventis Administrative Office
Seoul, South Korea
Sanofi-Aventis Administrative Office
Mégrine, Tunisia
Sanofi-Aventis Administrative Office
Kiev, Ukraine
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
December 12, 2016
Results First Posted
December 12, 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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