Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
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