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

Type 2 Diabetes Mellitus Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

The total study duration is approximately 10-15 weeks. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight
• Type 2 Diabetes Mellitus

• NCT number: NCT02411825
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 1
• Start date: March 2015
• Completion date: January 2016