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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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 296 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02973321
The ClinicalTrials.gov registry entry for NCT02973321 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 296 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 4 interventions - of which Placebo is the first listed.
NCT02973321 reports 0 study locations.
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.
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