A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus
Status:
Completed
Trial end date:
2017-12-27
Target enrollment:
Participant gender:
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.