A 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 T1DM

Summary

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.

Timeline

Start

2016-04

Primary completion

2016-08

Completion

2016-08

Drugs

Indications