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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


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

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