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 facilitation of the absorption of the insulin after subcutaneous injection. The aim of the trial is to investigate the dose-response and the dose-exposure relationships of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and to assess safety and tolerability of BioChaperone insulin lispro and Humalog®. This is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of Humalog® (0.2 U/Kg) on 4 separate dosing visits.
Interventions
DRUGBioChaperone insulin lispro 0.2U/Kg
Single dose of 0.2U/Kg body weight injected subcutaneously
DRUGBioChaperone insulin lispro 0.1U/Kg
Single dose of 0.1U/Kg body weight injected subcutaneously
DRUGBioChaperone insulin lispro 0.4U/Kg
Single dose of 0.4U/Kg body weight injected subcutaneously
DRUGHumalog®
Single dose of 0.2U/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
* Type 1 diabetes mellitus for at least 12 months * Treated with multiple daily insulin injections of insulin pump for at least 12 months * Body Mass Index (BMI): 18.5-28.0 Kg.m²
Exclusion criteria
* Type 2 diabetes mellitus * Receipt of any investigational product within 3 months prior 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 1 year prior to screening * Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic endpoint: Cmax(Lisp) | 12 hours | Maximum observed serum insulin lispro concentration |
| Glucodynamic endpoint: Area Under the Curve GIR(0-last) | 12 hours | Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp |
| Glucodynamic endpoint: GIRMax | 12 hours | Maximum Glucose Infusion Rate |
| Pharmacokinetic endpoint: AUC Lisp(0-last) | 12 hours | Area under the insulin lispro serum concentration - time curve over the clamp procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Tmax(lisp) | 12 hours | Time to maximum observed serum insulin lispro concentration |
| Glucodynamic: TGIRmax | 12 hours | Time to maximum Glucose Infusion Rate |
| Tonset of action | 12 hours | Time from t=0 until blood glucose concentration has decreased by 5mg.dL (0.3mmol.L) from baseline. |
| Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters. | 12 weeks | — |
Countries
Germany
Outcome results
None listed