Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)

Type 1 Diabetes Mellitus Clinical Trial

Official title: Randomized, Double-blind, Euglycemic Glucose Clamp Study of Four Formulations of SAR161271, in Single Doses in Healthy Subjects and Single Ascending Doses in Patients With Type 1 Diabetes Mellitus

Status Completed

Clinical Trial Summary

Primary Objective:

• To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.

Secondary Objective:

• To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM

Clinical Trial Description

The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. In case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows:

• Screening: 3 to 27 days;

• Treatment Periods each 1 day with institutionalisation from Day -1 to Day 3;

• Wash-out between doses: 7 to 10 days;

• End of Study visit: 7 to 10 days after last dose.

• Post-study visit 84 to 112 days after last dosing. If necessary, additional post-study visit 6 to 7 months after last dosing. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT01053728
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2010
• Completion date: November 2010