Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal

Study Overview
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Brief Summary
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The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection. This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus. This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.

Official Title
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Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal

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 ≥ 12 months Treated with multiple daily insulin injections or CSII ≥ 12 months BMI 18.5-28.0 kg/m² (both inclusive) HbA1C%≤9% Exclusion Criteria: Type 2 Diabetes Mellitus Receipt of any trial product within 60 days prior to this trial Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption. Any systemic treatment with drugs known to interfere with glucose metabolism Use of any tobacco or nicotine-contained product within one year 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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All

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biochaperone Insulin Lispro<br> | Drug: BioChaperone insulin lispro<br>* Single dose of 0.2 U/kg body weight injected subcutaneously<br>|
| Active Comparator: Humalog®<br> | Drug: Humalog®<br>* Single dose of 0.2 U/kg body weight injected subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the blood glucose time curve: AUCbg(0-2h) | Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h) |  | 8 hours | 
| Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax |  | 8 hours | 
| Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h) |  | 8 hours | 
| Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp) |  | 8 hours | 
| Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters |  | Up to 7 weeks |