NCT02213146

A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Adocia · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection. The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg. This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 separate dosing visits.

Conditions

• Diabetes Mellitus Type 1

Interventions

Type	Name	Description
DRUG	BioChaperone human insulin	Single dose of 0.2 U/kg body weight injected subcutaneously
DRUG	Huminsulin® Normal	Single dose of 0.2 U/kg body weight injected subcutaneously
DRUG	Humalog®	Single dose of 0.2 U/kg body weight injected subcutaneously

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2014-08-11
• Last updated: 2017-06-01

Locations

1 site across 1 country: Germany