Type1 Diabetes Mellitus
Conditions
Brief summary
This is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. In a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 U/kg body weight. Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.
Interventions
DRUGBioChaperone® insulin lispro
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
DRUGFiasp®
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
DRUGNovorapid®
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Sponsors
Adocia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 Diabetes Mellitus for more than 12 months. * BMI between 18.5 and 28.5 kg/m². * HbA1C level \<=9.0%. * Insulin treated for at least 12 months with total insulin dose \<1.2U/kg/day.
Exclusion criteria
* Type 2 Diabetes Mellitus. * History of multiple and/or severe allergies to drugs or foods. * Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator. * More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months. * Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy. * Females of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCGIR(0-60min) | 60 minutes | Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TmaxGIR | 10 hours | Time from bolus administration to maximum baseline corrected glucose infusion rate |
| GIRmax | 10 hours | Maximum baseline corrected glucose infusion rate |
| Adverse Events | up to 8 weeks | Number of Adverse Events in each arm |
| AUCins(0-30min) | 30 minutes | Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration |
| Clinical safety laboratory | up to 8 weeks | Haematology, biochemistry and urinalysis: changes and findings from Baseline in clinical safety laboratory parameters during the trial duration, from screening, and at follow-up visit. |
| AUCins(0-600min) | 600 minutes | Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration |
| Cmax insulin | 10 hours | Maximum observed baseline corrected insulin concentration |
| Tmax insulin | 10 hours | Time from bolus administration to baseline corrected Cmax |
| AUCins(0-60min) | 60 minutes | Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration |
Countries
Germany
Outcome results
None listed