A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

Status:	Completed
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 80
Updated:	12/9/2018
Start Date:	December 2, 2016
End Date:	December 27, 2017

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

Primary Objective:

The primary objective of this study is 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 patients achieving predefined HbA1c targets of <7% and <6.5%
as well as the proportion of patients 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 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.

Inclusion criteria :

- Patients 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, patient'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 patient's
potential participation in a clinical trial.

We found this trial at

sites

Clinical Trial Facility in Austin Texas

Austin, Texas 78744

from

Austin, TX