Diabetes Mellitus, Type 1
Conditions
Brief summary
This study is looking at how five different formulations of faster aspart 200 U/mL reach and stay in the blood after injection. The purpose is to find a formulation that behaves similarly to the reference product called faster aspart 100 U/mL (marketed as Fiasp®). The participant will get all five formulations and the reference product. The order in which the participant gets them is decided by chance. The participant will get each medicine once during the study meaning that the participant will get a total of six injections with study medicine. The medicine will be injected under the skin in the stomach. The study will last for about 2 to 21 weeks depending on individual visit schedule. The participant will have nine clinic visits with the study doctor (including the one in which the participant give consent).
Interventions
DRUGFaster Aspart 200 U/mL
A single dose (0.15 U/kg) of five formulations of fast-acting insulin aspart 200 U/mL (formulations A, B, C, D, E) in a sequential manner via subcutaneous injection.
DRUGFaster aspart 100 U/mL
A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is asked according to company standard procedures
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening * Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion greater than or equal to 1 year prior to the day of screening
Exclusion criteria
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening in this trial * Blood donation, plasma donation or blood draw, defined as any of the below: In excess of 400 mL within the past 90 days prior to the day of screening OR In excess of 50 mL within the past 30 days prior to the day of screening * Use of tobacco and nicotine products, defined as any of the below: Smoking more than 1 cigarette or the equivalent per day OR Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house periods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure | 0 to 10 hours after IMP administration | Measured in pmol\*h/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration | 0 to 2 hours after IMP administration | Measured in pmol\*h/L |
| AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity | 0 to 10 hours after IMP administration | Measured in pmol\*h/L |
| Cmax,IAsp - Maximum observed serum insulin aspart concentration | 0 to 10 hours after IMP administration | Measured in pmol/L |
| AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration | 0 to 1 hour after IMP administration | Measured in pmol\*h/L |
| Number of adverse events in the treatment emergent period | 0 to 2 days after IMP administration | Count of events |
| Number of local reactions at the injection site in the treatment emergent period | 0 to 2 days after IMP administration | Count of injection site reactions |
| Number of hypoglycaemic episodes in the treatment emergent period | 0 to 16 hours after IMP administration | Count of hypoglycaemic episodes |
| tmax,IAsp - Time to maximum observed serum insulin aspart concentration | 0 to 10 hours after IMP administration | Measured in minutes |
Countries
Germany
Outcome results
None listed