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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02973321

Run by

Sanofi

People needed

296

Starts

2016-12-02

Expected to finish

2017-12-27

Last updated by the study team

2022-03-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 8400002 — Huntington Park, California, United States
• Investigational Site Number 8400024 — Los Angeles, California, United States
• Investigational Site Number 8400001 — Los Angeles, California, United States
• Investigational Site Number 8400012 — Port Hueneme, California, United States
• Investigational Site Number 8400027 — Denver, Colorado, United States
• Investigational Site Number 8400025 — Miami, Florida, United States
• Investigational Site Number 8400007 — Palm Harbor, Florida, United States
• Investigational Site Number 8400013 — Chicago, Illinois, United States
• Investigational Site Number 8400016 — Wichita, Kansas, United States
• Investigational Site Number 8400023 — Wichita, Kansas, United States
• Investigational Site Number 8400018 — New Orleans, Louisiana, United States
• Investigational Site Number 8400019 — Rockville, Maryland, United States
• Investigational Site Number 8400014 — Flint, Michigan, United States
• Investigational Site Number 8400003 — Troy, Michigan, United States
• Investigational Site Number 8400020 — Linden, New Jersey, United States
• Investigational Site Number 8400022 — New York, New York, United States
• Investigational Site Number 8400005 — Fargo, North Dakota, United States
• Investigational Site Number 8400004 — Austin, Texas, United States
• Investigational Site Number 8400006 — Dallas, Texas, United States
• Investigational Site Number 8400021 — Houston, Texas, United States
• Investigational Site Number 8400026 — San Antonio, Texas, United States
• Investigational Site Number 8400017 — Sugar Land, Texas, United States
• Investigational Site Number 1240008 — Québec, Canada
• Investigational Site Number 1240005 — Sainte-Foy, Canada
• Investigational Site Number 8400028 — Sheffield, Alabama, United States

Full record on ClinicalTrials.gov

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