A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus
Public ClinicalTrials.gov record NCT02973321. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02973321
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 296 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2, 2016 (Actual)
- Primary completion
- Dec 27, 2017 (Actual)
- Completion
- Dec 27, 2017 (Actual)
- Last update posted
- Mar 24, 2022
2016 – 2017
United States locations
- U.S. sites
- 23
- U.S. states
- 13
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400028 | Sheffield | Alabama | 35660 | — |
| Investigational Site Number 8400002 | Huntington Park | California | 90255 | — |
| Investigational Site Number 8400024 | Los Angeles | California | 90017 | — |
| Investigational Site Number 8400001 | Los Angeles | California | 90057 | — |
| Investigational Site Number 8400012 | Port Hueneme | California | 93041 | — |
| Investigational Site Number 8400027 | Denver | Colorado | 80209 | — |
| Investigational Site Number 8400025 | Miami | Florida | 33166 | — |
| Investigational Site Number 8400007 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 8400013 | Chicago | Illinois | 60827 | — |
| Investigational Site Number 8400016 | Wichita | Kansas | 67205 | — |
| Investigational Site Number 8400023 | Wichita | Kansas | 67207 | — |
| Investigational Site Number 8400018 | New Orleans | Louisiana | 70119 | — |
| Investigational Site Number 8400019 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 8400014 | Flint | Michigan | 48532-3447 | — |
| Investigational Site Number 8400003 | Troy | Michigan | 48085 | — |
| Investigational Site Number 8400020 | Linden | New Jersey | 07036 | — |
| Investigational Site Number 8400022 | New York | New York | 10001 | — |
| Investigational Site Number 8400005 | Fargo | North Dakota | 58103 | — |
| Investigational Site Number 8400004 | Austin | Texas | 78731 | — |
| Investigational Site Number 8400006 | Dallas | Texas | 75230 | — |
| Investigational Site Number 8400021 | Houston | Texas | 77079 | — |
| Investigational Site Number 8400026 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 8400017 | Sugar Land | Texas | 77478 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02973321, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02973321 live on ClinicalTrials.gov.