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NCT00976937 · ClinicalTrials.gov registry record · Phase 3
24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 319
- Enrollment target
NCT00976937 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 319 participants.
The verdict
NCT00976937, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 319 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index \[BMI\] greater than or equal to 30 kilogram per square meter \[kg/m\^2\]) type 2 diabetic patients less than 50 years of age, over a period of 24 weeks of treatment. The primary objective of this study is to assess the efficacy of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24. Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on absolute changes in HbA1c values and body weight; fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and anti-lixisenatide antibody development.
Interventions
- DRUG Sitagliptin
- DRUG Lixisenatide (AVE0010)
- DEVICE Pen auto-injector
- DRUG Lixisenatide Placebo
- DRUG Sitagliptin Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00976937
The ClinicalTrials.gov registry entry for NCT00976937 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 319 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Sitagliptin is the first listed.
NCT00976937 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00976937 about?
NCT00976937 is a clinical study titled "24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years". The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index \[BMI\] greater than or equal to 30 kilogram per square meter \[kg/m\^2\]) type 2 diabetic patients less than 50 years o...
What is the current status of trial NCT00976937?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2009-08. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00976937?
The interventions under investigation include: Sitagliptin (DRUG), Lixisenatide (AVE0010) (DRUG), Pen auto-injector (DEVICE), Lixisenatide Placebo (DRUG), Sitagliptin Placebo (DRUG).
Who is sponsoring clinical trial NCT00976937?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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