NCT02411825

Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus (T2DM) Patients

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Repeated Subcutaneous Doses of SAR425899 in Healthy Male Subjects and Overweight to Obese Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	SAR425899	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	placebo	Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG	metformin	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-04-08
• Last updated: 2018-06-15

Locations

1 site across 1 country: Germany