A Phase 1 interventional study of NNC0363-1063 in Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 36 is close to the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
Drug: NNC0363-1063
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
Drug: NNC0363-1063
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
Drug: NNC0363-1063
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
Drug: NNC0363-1063
NNC0363-1063 will be administered subcutaneously.
AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state
Measured in milligrams per kilogram (mg/kg).
Time frame: Visit 2 and 3: Day 2 and 3
GIRmax,SS: Maximum glucose infusion rate at steady state
Measured in milligrams per kilogram\*minute (mg/\[kg\*min\]).
Time frame: Visit 2 and 3: Day 2 and 3
Time to maximum glucose infusion rate (tGIRmax),SS: Time to maximum glucose infusion rate at steady state
Measured in hours.
Time frame: Visit 2 and 3: Day 2 and 3
AUC,I1063,SS: Area under the serum NNC0363-1063 concentration time curve at steady state
Measured in hours\*picomoles per litre (h\*pmol/L).
Time frame: Visit 2 and 3: Day 2 and 3
Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration at steady state
Measured in picomoles per litre (pmol/L).
Time frame: Visit 2 and 3: Day 2 and 3
tmax,I1063,SS: Time to maximum observed serum NNC0363-1063 concentration at steady state
Measured in hours.
Time frame: Visit 2 and 3: Day 2 and 3
Number of adverse events
Measured as number of events.
Time frame: Visit 2 and 3: Day 2 and 3
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S