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

NCT02973321

CompletedPhase 2

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

Interventions: SAR425899, Placebo, Liraglutide, Metformin

Countries: United States, Canada, Czechia, Germany, Hungary, Mexico, Russia, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (59)
  • Sheffield, Alabama, United States
  • Huntington Park, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Port Hueneme, California, United States
  • Denver, Colorado, United States
  • Miami, Florida, United States
  • Palm Harbor, Florida, United States
  • Chicago, Illinois, United States
  • Wichita, Kansas, United States
  • Wichita, Kansas, United States
  • New Orleans, Louisiana, United States
  • Rockville, Maryland, United States
  • Flint, Michigan, United States
  • Troy, Michigan, United States
  • Linden, New Jersey, United States
  • New York, New York, United States
  • Fargo, North Dakota, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Sugar Land, Texas, United States
  • Québec, Canada
  • Sainte-Foy, Canada
  • Sherbrooke, Canada
  • Toronto, Canada
  • Vancouver, Canada
  • České Budějovice, Czechia
  • Krnov, Czechia
  • + 29 more on CT.gov