Trial intelligence / Profile preview

SAR161271 in Type 1 Diabetes Mellitus

NCT01053728Phase 2

Key facts

Status: Completed
Start: Feb 2010
Primary completion: May 2010
Countries: 1
Sponsor: Sanofi
Modality: Peptides, Small Molecules

Drugs: SAR161271
Conditions: type 1 diabetes mellitus (T1D)

Overview

Phase 2, randomised, double-blind trial of SAR161271 in type 1 diabetes mellitus (T1D) (3 cohorts), sponsored by Sanofi. Primary endpoints: Safety and Tolerability at 7 days and Glucose Infusion Rate at 30 hours. Started Feb 2010; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Cohort 1 (0.3 U/kg)
Crossover comparison of SAR161271 formulations and insulin glargine at 0.3 U/kg dose.
Cohort 2 (0.6 U/kg)
Crossover comparison of SAR161271 formulations and insulin glargine at 0.6 U/kg dose.
Cohort 3 (1.2 U/kg)
Crossover comparison of SAR161271 formulations and insulin glargine at 1.2 U/kg dose.

Endpoints

Primary

Safety and Tolerability7 days
Glucose Infusion Rate30 hours

Secondary

Pharmacokinetic parameters168 hours
Anti-insulin antibody productionafter 4th dose

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