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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adocia
• Treatments: Biphasic Insulins; Insulin Lispro; Insulin, Isophane

Criteria

Inclusion Criteria:

• Type 1 diabetes mellitus for at least (or equal to ) 12 months,

• Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,

• Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive)

Exclusion Criteria:

• Type 2 diabetes mellitus,

• The receipt of any investigational product within 3 month prior to first dosing,

• Clinically significant abnormalities, as judged by the investigator,

• Any systemic treatment with drugs known to interfere with glucose metabolism,

• History of alcoholism or drug/chemical abuse and any tobacco product within 5 years prior to screening

• Blood or plasma donation in the past month or more than 500mL within 3 months prior to screening