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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Adocia
- Enrollment
- 37
- Primary Endpoint
- Area under the curve (AUC)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
BioChaperone insulin lispro
BioChaperone insulin lispro
Intervention: BioChaperone insulin lispro (Drug)
Humalog®
Humalog®
Intervention: Humalog® (Drug)
Outcomes
Primary Outcomes
Area under the curve (AUC)
Time Frame: 30 minutes
Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes
Secondary Outcomes
- Pharmacokinetics: Early t0.5max(Lisp)(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)(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)