Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus (T2DM) Patients
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02411825
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess in healthy adult male subjects:
* The tolerability and safety of 21-day repeated subcutaneous (SC) doses of SAR425899 including two up titration steps.
* Pharmacokinetic (PK) parameters of SAR425899 after ascending repeated SC doses in plasma.
* Pharmacodynamic (PD) effects on fasting and postprandial plasma glucose, insulin, biomarkers of lipid metabolism and fibroblast growth factor 21 (FGF21).
To assess in overweight to obese T2DM mellitus patients:
* The tolerability and safety after 28-day repeated SC doses of SAR425899 including 2 up titration steps.
* PK parameters of SAR425899 after ascending repeated SC doses in plasma and urine.
* PD effects on fasting and postprandial plasma glucose, insulin, C-peptide, incretin panel (total and active ghrelin, total peptide YY \[PYY\], total and active glucagon-like peptide -1 \[GLP-1\], glucagon and total gastric inhibitory polypeptide-1 \[GIP\]), body weight, FGF21, biomarkers of lipid metabolism and HbA1c.
- Detailed Description
The total study duration is approximately 10-15 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (T2DM Patients) placebo Once daily SC doses of placebo and two up titration steps in each dose cohort with metformin as background therapy SAR425899 (healthy subjects) SAR425899 Once daily SC doses of SAR425899 SAR425899 (T2DM Patients) SAR425899 Once daily SC doses of SAR425899 and two up titration steps in each dose cohort with metformin as background therapy SAR425899 (T2DM Patients) metformin Once daily SC doses of SAR425899 and two up titration steps in each dose cohort with metformin as background therapy Placebo (healthy subjects) placebo Once daily SC doses of placebo Placebo (T2DM Patients) metformin Once daily SC doses of placebo and two up titration steps in each dose cohort with metformin as background therapy
- Primary Outcome Measures
Name Time Method Number of adverse events 28 to 35 days
- Secondary Outcome Measures
Name Time Method Changes in ECG 28 to 35 days Changes in clinical laboratory parameters (hematology) 28 to 35 days Changes in vital signs 28 to 35 days Changes in physical examination 28 to 35 days Changes in body temperature 28 to 35 days Change from baseline in biomarkers (FGF21) 28 to 35 days Changes in clinical laboratory parameters (biochemistry) 28 to 35 days Change from baseline in biomarkers (lipid biomarker) 28 to 35 days Change from baseline in biomarkers (incretins) 28 to 35 days Assessment of pharmacokinetic parameters in blood (AUC) 28 to 35 days Assessment of pharmacokinetic parameters in blood (Cmax) 28 to 35 days Assessment of pharmacokinetic parameters in blood (t1/2) 28 to 35 days Assessment of pharmacokinetic parameters in urine (Ae0-24) 28 to 35 days Assessment of pharmacokinetic parameters in urine (fe0-24) 28 to 35 days Change from baseline in Body weight 28 to 35 days Change from baseline in Fasting Blood Glucose 28 to 35 days Change from baseline in Postprandial Blood Glucose 28 to 35 days Change from baseline in postprandial Insulin 28 to 35 days Change from baseline in postprandial C-peptide profiles 28 to 35 days Change from baseline in HbA1c 28 to 35 days
Trial Locations
- Locations (1)
Investigational Site Number 276001
🇩🇪Berlin, Germany