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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: Humalog® Mix25; Drug: BioChaperone® Combo

• Registration Number: NCT01981031
• Lead Sponsor: Adocia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-31
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-11
• Primary Completion: 2013-12
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Humalog® Mix25	Drug: Humalog® Mix25
A	BioChaperone® Combo	Drug: BioChaperone® Combo

Primary Outcome Measures

Name	Time	Method
End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)	from 0 to 30 hours after a single-dose administration

Secondary Outcome Measures

Name	Time	Method
Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25	from 0 to 30 hours after a single-dose administration
Number of Adverse Events	Weeks 0-10	hypoglycemic events, local tolerability, adverse reactions