Type 1 Diabetes Mellitus Clinical Trial
Official title:
A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)
This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over
trial in subjects with type 1 diabetes mellitus.
Each subject will be administered individualised single subcutaneous doses of BioChaperone
Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin®
Normal) immediately before ingesting a standardised mixed meal.
Following trial drug administration, PK and PD assessments will be carried until 6 hours
after start of the standardized test meal.
The total trial duration for an individual subject will be up to 11 weeks.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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