Type 1 Diabetes Mellitus Clinical Trial
Primary Objective:
- To assess the total metabolic effect ratios of a new insulin glargine formulation versus
Lantus®
Secondary Objectives:
- To assess the exposure ratios of a new insulin glargine formulation versus Lantus®
- To compare the duration of action of a new insulin glargine formulation versus Lantus®
- To explore the dose response and dose exposure relationship of a new insulin glargine
formulation
- To assess the safety and tolerability of a new insulin glargine formulation
The study period for one patient is one month in average and it can last up to 11 weeks
broken down as follows:
- Screening: 3 to 28 days
- Treatment period: 1 to 4 days: 2 days (1 overnight stay)
- Washout period: 5 to 18 days (preferentially 7 days between consecutive dosings)
- End of study: 1 day after the last dosing
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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