Diabetes Mellitus Type 1
Conditions
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.
Interventions
Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)
DRUGHumalog®
Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)
Sponsors
Adocia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) | 30 minutes | Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Glucodynamic: GIRmax (Maximum glucose infusion rate) | 6 hours | — |
| 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 |
| Pharmacokinetics: Early t0.5max(Lisp) | up to 6 hours post administration of study drug | Time to first observed half maximum observed insulin lispro concentration |
Countries
Germany
Outcome results
None listed