Type 1 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Cross-over, Open, Euglycemic Clamp Study on the Relative Bioavailability and Activity of 0.6 U/kg Insulin Glargine and 20 μg Lixisenatide, Given as On-site Mix Compared to Separate Simultaneous Injections in Subjects With Type 1 Diabetes Mellitus
Primary Objective:
- to assess the relative bioavailability of a single dose of insulin glargine (Lantus)
and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous
injections of each drug
Secondary Objectives:
- to compare the activity of a single dose of insulin glargine and lixisenatide given
subcutaneously as on-site mix versus separate and simultaneous injections of each drug
- to assess the safety and tolerability of insulin glargine and lixisenatide given
subcutaneously as on-site mix
The study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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