Type 1 Diabetes Mellitus Clinical Trial
Official title:
SAR438544 - Clinical & Exploratory Pharmacology
Primary Objective:
To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544
versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced
hypoglycemia.
Secondary Objective:
To assess the safety and tolerability and pharmacokinetics (PK) of a single SC dose of
SAR438544 versus recombinant glucagon in T1DM patients under induced hypoglycemia.
The total duration of study per patient is up to 8 weeks with 3 to 28 days screening period, 1 day for treatment for both periods and 7 to 14 days wash out between 2 administrations, and 7 days (+/- 1 day) follow-up after last IMP administration. ;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Basic Science
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