NCT02146651

A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes

• Status: Completed
• Phase: 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 insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection. The aim of the trial is to investigate the dose-response and the dose-exposure relationships of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and to assess safety and tolerability of BioChaperone insulin lispro and Humalog®. This is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of Humalog® (0.2 U/Kg) on 4 separate dosing visits.

Conditions

• Diabetes Mellitus Type 1

Interventions

Type	Name	Description
DRUG	BioChaperone insulin lispro 0.2U/Kg	Single dose of 0.2U/Kg body weight injected subcutaneously
DRUG	BioChaperone insulin lispro 0.1U/Kg	Single dose of 0.1U/Kg body weight injected subcutaneously
DRUG	BioChaperone insulin lispro 0.4U/Kg	Single dose of 0.4U/Kg body weight injected subcutaneously
DRUG	Humalog®	Single dose of 0.2U/Kg body weight injected subcutaneously

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2014-05-26
• Last updated: 2014-12-10

Locations

1 site across 1 country: Germany