NCT02739906

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

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	BioChaperone Human Insulin (HinsBet®)	BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake
DRUG	Insulin Lispro (Humalog®)	Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake
DRUG	Regular human insulin (Huminsulin® Normal)	Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-04-15
• Last updated: 2016-08-18

Locations

2 sites across 1 country: Germany