A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
- Conditions
- Diabetes Mellitus Type 1
- Interventions
- Registration Number
- NCT02213146
- Lead Sponsor
- Adocia
- Brief Summary
The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.
The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg.
This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 separate dosing visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 38
- Male subject with type 1 diabetes for at least 12 months
- Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months
- Body mass index: 18.5-28.0 kg BW·m-2
- HbA1c: ≤ 9.0%
- Diabetes mellitus type 2
- Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial
- 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 any tobacco or nicotine-contained product within one year prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BioChaperone human insulin BioChaperone human insulin BioChaperone Human Insulin BioChaperone human insulin Huminsulin® Normal BioChaperone Human Insulin BioChaperone human insulin Humalog® BioChaperone Human Insulin Human insulin Huminsulin® Normal Huminsulin® Normal Human insulin Humalog® Huminsulin® Normal Insulin lispro BioChaperone human insulin Humalog® Insulin lispro Huminsulin® Normal Humalog® Insulin lispro Humalog® Humalog® Human insulin BioChaperone human insulin Huminsulin® Normal
- Primary Outcome Measures
Name Time Method Area under the curve (AUCins(0-1h)) 1 hour Area under the human insulin serum concentration - time curve from t=0 to 1 hour
- Secondary Outcome Measures
Name Time Method Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters up to 7 weeks Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Pharmacokinetics: Cmax(ins/lisp) up to 10 hours Maximum observed human insulin / insulin lispro serum concentration
Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration 10 hours Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours
Pharmacokinetics: Early t0.5max ins/lisp up to 10 hours post administration Time to first observed half maximum serum human insulin / insulin lispro concentration
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours 10 hours Area under the glucose infusion rate - time curve from t=0 to 10 hours
Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax) 10 hours Time to first observed half maximum glucose infusion rate
Glucodynamics: GIRmax - Maximum glucose infusion rate 10 hours Maximum glucose infusion rate
Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration 10 hours Time to maximum observed serum human insulin concentration and insulin lispro concentration
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours 2 hours post administration Area under the glucose infusion rate - time curve from t=0 to 2 hours
Trial Locations
- Locations (1)
Profil GmbH
🇩🇪Neuss, Germany