Nutritional and metabolic diseases MedDRA version: 19.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Code: SAR425899
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
Current Sponsor code: SAR425899
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: -At screening, patient’s age 80 years. -Glycated hemoglobin at screening visit 10.0%. -Body mass index (BMI) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 Objective: -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, interindividual and inter-occasion variability in PK parameters using a population PK approach.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Change in body weight 2- Percentage of patients achieving predefined HbA1c targets of <7% Percentage of patients achieving predefined HbA1c targets of <6.5% 3- Percentage of patients achieving =5% body weight loss Percentage of patients achieving =10% body weight loss 4- Change in FPG Change in postprandial plasma glucose (PPG) in response to a standardized meal test in up to 50% subset of all patients 5- Percentage of patients requiring rescue therapy 6- Change from baseline in postprandial insulin in response to a standardized meal test in up to 50% subset of all patients 7- Change from baseline in proinsulin in response to a standardized meal test in up to 50% subset of all patients Change from baseline in C-peptide in response to a standardized meal test in up to 50% subset of all patients 8- Change in fasting lipid profile 9- Change in pharmacodynamic biomarkers 10- Assessment of PK parameter: oral clearance(CL/F) Assessment of PK parameter: volume distribution after nonintravenous infusion (Vz/F) Assessment of PK parameter: terminal half-life (T1/2);Timepoint(s) of evaluation of this end point: 1- From baseline to Week 26 2- At Week 26 3- At Week 26 4- From baseline to Week 26 5- During 26-week treatment period 6- From baseline to Week 26 7- From baseline to Week 26 8- From baseline to Week 26 9- From baseline to Week 26 10- Week 26 | — |
Countries
Canada, Czech Republic, Germany, Hungary, Mexico, Russian Federation, Spain, United States
Contacts
Public ContactUnidad de Estudios Clínicos
sanofi-aventis, s.a
Outcome results
None listed