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NCT02973321 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 296
- Enrollment target
NCT02973321: Completed Phase 2 study, sponsored by Sanofi.
NCT02973321 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 296 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02973321, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 296 participants
- Enrollment target
Study Summary
Primary Objective: The primary objective of this study was to assess the dose-response relationship of SAR425899 versus placebo in terms of glycemic control as measured by the change in glycosylated hemoglobin (HbA1c). Secondary Objectives: * To assess the effect of SAR425899 on body weight. * To assess the safety and immunogenicity profile of SAR425899, including assessment of the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor. * To assess the proportion of participants achieving predefined HbA1c targets of \<7% and \<6.5% as well as the proportion of participants achieving \>=5% and \>=10% body weight loss. * To assess the effect of once daily dosing of SAR425899 on additional parameters of glycemic control and lipid metabolism. * To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic (PD) biomarkers. * To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual and inter-occasion variability in PK parameters using a population PK approach.
Primary Outcome
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework.
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Liraglutide
- DRUG SAR425899
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2016-12-02 |
| Est. Completion | 2017-12-27 |
| Phase | Phase 2 |
What the finished NCT02973321 record still lists
NCT02973321 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02973321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02973321 about?
NCT02973321 is a clinical study titled "A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus". Primary Objective: The primary objective of this study was to assess the dose-response relationship of SAR425899 versus placebo in terms of glycemic control as measured by the change in glycosylated hemoglobin (HbA1c). Secondary Objectives: * To assess the effect of SAR425899 on body weight. * To...
What is the current status of trial NCT02973321?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 296 participants. The study started on 2016-12-02. Estimated completion is 2017-12-27.
What interventions are being tested in trial NCT02973321?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Liraglutide (DRUG), SAR425899 (DRUG).
Who is sponsoring clinical trial NCT02973321?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02973321's enrollment target sits among peer trials
296 189th of 2000 higher than 1,812 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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