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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Liraglutide; Metformin

Criteria

Inclusion criteria :

• Participants with type-2 diabetes mellitus (T2DM) for at least 3 months before the screening visit.

• On diet/exercise and/or treatment with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 3 months prior to screening.

• Signed informed consent.

Exclusion criteria:

• At screening, participant's age < legal age of adulthood and >80 years.

• Glycated hemoglobin at screening visit <7.0% or >10.0%.

• Body mass index (BMI) <25 kg/m^2 or >45.0 kg/m^2.

• Pregnant or lactating women.

• Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.

• Diagnosis of type 1 diabetes mellitus.

• Fasting plasma glucose of >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.

• Treatment with glucose-lowering agents(s) other than metformin, currently or within the 3 months prior to screening.

• Previous insulin use, except for episode(s) of short-term treatment (≤15 consecutive days) for intercurrent illness or pregnancy, or use of insulin within the last 6 months.

• Contraindication(s) to metformin use.

• Contraindication(s) to liraglutide use.

• Significant change in body weight in the 3 months before screening.

• Poorly controlled hypertension (a resting systolic blood pressure (SBP) >160 mm Hg and/or diastolic blood pressure (DBP) >95 mm Hg at screening).

• History of long QT syndrome and/or QTc more than 450 ms at screening visit.

• History of pancreatitis or pancreatectomy.

• History of weight loss surgery.

• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.

• Any prior exposure to drugs belonging to the class of glucagon-like peptide-1 (GLP-1) receptor agonists/GLP-1 analogs.

• Contraindications or known hypersensitivity reaction to glucagon.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.