Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus

Type1 Diabetes Clinical Trial

Official title: A Double-blind, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two New Insulin Glargine Formulations Using the Euglycemic Clamp Technique in Subjects With Type 1 Diabetes Mellitus

Status Completed

Clinical Trial Summary

Primary Objective:

To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses

Secondary Objective:

• To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the insulin glargine reference formulation R in steady state conditions after 6 once-daily SC doses

• To assess the safety and tolerability of the test and reference formulations of two new insulin glargine formulations

Clinical Trial Description

Total study duration per subject: 29 to 64 days including screening visit

Duration of each part of the study for one subject:

• Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3)

• Treatment Period 1 and 2: 8 days (dosing on 6 days)

• Washout between last/1st dosing days of the treatment periods: 7-21 days (preferentially 7 days) End-of-Study Visit: 7-10 days 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
• Type1 Diabetes

• NCT number: NCT01838083
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 1
• Start date: April 2013
• Completion date: August 2013