Diabetes Mellitus, Type 1
Conditions
Brief summary
The purpose of this clinical study is to find out how the novel insulin NNC0363-1063 and a non-glucose carbohydrate used in food and beverage might interact in participants with type 1 diabetes and if co-administration of these substances is safe and tolerable. All participants will get a fixed dose of NNC0363-1063 and an oral administration of different amounts of the non-glucose carbohydrate in a random order during 4 interaction tests. The participants will be in this clinical study for about 5 to 12 weeks.
Interventions
DRUGNNC0363-1063
NNC0363-1063 will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female participant (sex at birth) of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e., documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 month without an alternative medical cause) prior to the day of screening. * Age 18-64 years (both inclusive) at the time of signing informed consent. * Body mass index between 18.5-29.9 Kilogram Per Square Meter (kg/m\^2) (both inclusive) at the day of screening. * 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 ≥ 90 days prior to the day of screening. * Glycated haemoglobin (HbA1c) less than or equal to (≤ ) 9.0 percentage (%) at the day of screening.
Exclusion criteria
* Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method. * Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state | Visit 2 and 3: Day 2 and 3 | Measured in milligrams per kilogram (mg/kg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GIRmax,SS: Maximum glucose infusion rate at steady state | Visit 2 and 3: Day 2 and 3 | Measured in milligrams per kilogram\*minute (mg/\[kg\*min\]). |
| Time to maximum glucose infusion rate (tGIRmax),SS: Time to maximum glucose infusion rate at steady state | Visit 2 and 3: Day 2 and 3 | Measured in hours. |
| AUC,I1063,SS: Area under the serum NNC0363-1063 concentration time curve at steady state | Visit 2 and 3: Day 2 and 3 | Measured in hours\*picomoles per litre (h\*pmol/L). |
| Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration at steady state | Visit 2 and 3: Day 2 and 3 | Measured in picomoles per litre (pmol/L). |
| tmax,I1063,SS: Time to maximum observed serum NNC0363-1063 concentration at steady state | Visit 2 and 3: Day 2 and 3 | Measured in hours. |
| Number of adverse events | Visit 2 and 3: Day 2 and 3 | Measured as number of events. |
Countries
Germany
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed