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 Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BioChaperone insulin lispro BioChaperone insulin lispro |
Drug: BioChaperone insulin lispro
Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)
|
| Active Comparator: Humalog® Humalog® |
Drug: Humalog®
Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)
|
Outcome Measures
Primary Outcome Measures
- Area under the curve (AUC) [30 minutes]
Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes
Secondary Outcome Measures
- Pharmacokinetics: Early t0.5max(Lisp) [up to 6 hours post administration of study drug]
Time to first observed half maximum observed insulin lispro concentration
- Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours [6 hours]
- Glucodynamics: Early t0.5(GIRmax) [6 hours]
Time to first observed half maximum glucose infusion rate
- 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]
Eligibility Criteria
Criteria
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:
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Type 2 diabetes mellitus.
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Receipt of any investigational product within 3 months prior to first dosing.
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Clinically significant abnormalities as judged by the investigator.
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Any systemic treatment with drugs known to interfere with glucose metabolism.
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History of alcoholism, or drug/chemical abuse as per Investigator's judgement.
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Use of tobacco or nicotine-contained product within 5 years prior to screening.
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Blood or plasma donation in the past month or more than 500 mL within 3 months prior to screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neuss | Germany | 41460 |
Sponsors and Collaborators
- Adocia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BC3-CT006