NCT02029924

A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Adocia · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection. The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg. This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.

Conditions

• Diabetes Mellitus Type 1

Interventions

Type	Name	Description
DRUG	BioChaperone insulin lispro	Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)
DRUG	Humalog®	Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-03-01
• Completion: 2014-08-01
• First posted: 2014-01-08
• Last updated: 2017-06-01

Locations

1 site across 1 country: Germany