Diabetes Mellitus Type 1
Conditions
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.
Interventions
DRUGBioChaperone human insulin
Single dose of 0.2 U/kg body weight injected subcutaneously
DRUGHuminsulin® Normal
Single dose of 0.2 U/kg body weight injected subcutaneously
DRUGHumalog®
Single dose of 0.2 U/kg body weight injected subcutaneously
Sponsors
Adocia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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%
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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 |
| 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 |
| 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 |
| 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 |
Countries
Germany
Outcome results
None listed