A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

Adocia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetes Mellitus Type 1

Treatments: Drug: BioChaperone human insulin; Drug: Humalog®; Drug: Huminsulin® Normal

Study type: Interventional

Funder types: Industry

Identifiers

NCT02213146

BC3-CT010

Details and patient eligibility

About

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.

The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg.

This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 separate dosing visits.

Enrollment: 38 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male subject with type 1 diabetes for at least 12 months
• Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months
• Body mass index: 18.5-28.0 kg BW·m-2
• HbA1c: ≤ 9.0%

Exclusion criteria

• Diabetes mellitus type 2
• Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial
• 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 as per Investigator's judgement
• Use of any tobacco or nicotine-contained product within one year prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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38 participants in 3 patient groups

BioChaperone human insulin

Experimental group

Description:

BioChaperone Human Insulin

Treatment:

Drug: Huminsulin® Normal

Drug: BioChaperone human insulin

Drug: Humalog®

Human insulin

Active Comparator group

Description:

Huminsulin® Normal

Treatment:

Drug: Huminsulin® Normal

Drug: BioChaperone human insulin

Drug: Humalog®

Insulin lispro

Active Comparator group

Description:

Humalog®

Treatment:

Drug: Huminsulin® Normal

Drug: BioChaperone human insulin

Drug: Humalog®