Diabetes Mellitus Type 1
Conditions
Brief summary
The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection. This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus. This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.
Interventions
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
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 Diabetes Mellitus ≥ 12 months * Treated with multiple daily insulin injections or CSII ≥ 12 months * BMI 18.5-28.0 kg/m² (both inclusive) * HbA1C%≤9%
Exclusion criteria
* Type 2 Diabetes Mellitus * Receipt of any trial product within 60 days prior to this trial * Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease * Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator * Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption. * Any systemic treatment with drugs known to interfere with glucose metabolism * Use of any tobacco or nicotine-contained product within one year prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the blood glucose time curve: AUCbg(0-2h) | 2 hours | Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters | Up to 7 weeks |
| Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h) | 8 hours |
| Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax | 8 hours |
| Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h) | 8 hours |
| Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp) | 8 hours |
Countries
Germany
Outcome results
None listed