Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02973321
Status:
COMPLETED
Last Update Posted:
2022-03-24
First Post:
2016-11-22
Brief Title:
A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 65 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
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 65 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
Detailed Description:
The total study duration will be approximately 30 weeks consisting of 3 weeks screening period at the site a 26 weeks treatment period and 3 days post treatment follow up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-001328-77 | EUDRACT_NUMBER | None | None |
| U1111-1179-4786 | OTHER | UTN | None |