At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes mellitus diagnosis for at least 3 months before screening
- ✓On diet/exercise and/or metformin at stable dose ≥1500 mg/day or maximal tolerated dose for at least 3 months prior to screening
- ✓Signed informed consent
- ✕Age <legal age of adulthood or >80 years
- ✕HbA1c <7.0% or >10.0% at screening
- ✕BMI <25 kg/m² or >45.0 kg/m²
- ✕Pregnant or lactating women
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SAR425899, Placebo, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 296 participants across 59 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
Self-administered by SC injection using a solution for injection in cartridge.
Self-administered by SC injection using a solution for injection in cartridge.
Self-administered by SC injection using a pre-filled pen.
Orally administered at a stable dose , \>=1500 mg daily stable dose or maximal tolerated dose.