NCT01838083

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Type1 Diabetes

Interventions

Type	Name	Description
DRUG	Insulin glargine new formulation HOE901	Pharmaceutical form: solution Route of administration: subcutaneous

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-04-23
• Last updated: 2013-08-13

Locations

1 site across 1 country: Germany