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

Phase 1

• Conditions: utritional and metabolic diseases; MedDRA version: 19.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-001328-77-ES
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-07
• Last Update Posted: 5 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified