A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

Study Overview
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Brief Summary
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The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection. The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg. This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.

Official Title
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A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

Conditions
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Diabetes Mellitus Type 1

Intervention / Treatment
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* Drug: BioChaperone insulin lispro
* Drug: Humalog®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes mellitus for at least 12 months. Treated with multiple daily insulin injections or insulin pump for at least 12 months. Body Mass Index (BMI): 18.0-28.0 Kg/m². Exclusion Criteria: Type 2 diabetes mellitus. Receipt of any investigational product within 3 months 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 as per Investigator's judgement. Use of tobacco or nicotine-contained product within 5 years prior to screening. Blood or plasma donation in the past month or more than 500 mL 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: BioChaperone insulin lispro<br>BioChaperone insulin lispro | Drug: BioChaperone insulin lispro<br>* Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)<br>|
| Active Comparator: Humalog®<br>Humalog® | Drug: Humalog®<br>* Single dose of 0.2 /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 |
| --- | --- | --- |
| Area under the curve (AUC) | Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Early t0.5max(Lisp) | Time to first observed half maximum observed insulin lispro concentration | up to 6 hours post administration of study drug | 
| Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours |  | 6 hours | 
| Glucodynamics: Early t0.5(GIRmax) | Time to first observed half maximum glucose infusion rate | 6 hours | 
| Glucodynamic: GIRmax (Maximum glucose infusion rate) |  | 6 hours | 
| Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours |  | 6 hours | 
| Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration |  | 6 hours | 
| Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters |  | 8 weeks |