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Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

Official title:
A Randomized, Double-blind, 3-sequence, 3-period Cross-over, Single-dose Study of a New Formulation of Insulin Glargine Compared to the Marketed Lantus® in Japanese Patients With Type 1 Diabetes Mellitus Using the Euglycemic Clamp Technique

Clinical Trial Summary

Primary Objective:

To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus®

Secondary Objective:

To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation

Clinical Trial Description

The study duration per patient will be 4 to 12 weeks including 3 treatment periods each separated by a wash-out period of 6-20 days ;

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

Clinical Trial Details
NCT number NCT01493115
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date November 2011
Completion date April 2012
View Details
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