NCT01981031

A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes

Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 in Subjects With Type 1 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Adocia · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro. The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg. This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate dosing visits.

Conditions

• Diabetes
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	BioChaperone® Combo	Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
DRUG	Humalog® Mix25	Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)

Timeline

• Start date: 2013-11-01
• Primary completion: 2013-12-01
• Completion: 2014-08-01
• First posted: 2013-11-11
• Last updated: 2017-06-01

Locations

1 site across 1 country: Germany