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

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

Timeline

Start

2013-04

Primary completion

2013-08

Completion

2013-08

Drugs

Indications