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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: BioChaperone® Combo
* Drug: Humalog® Mix25


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Drug: BioChaperone® Combo | Drug: BioChaperone® Combo<br>* Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)<br>|
| Active Comparator: B<br>Drug: Humalog® Mix25 | Drug: Humalog® Mix25<br>* Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | hypoglycemic events, local tolerability, adverse reactions | Weeks 0-10 |