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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1317-2815 | Other Identifier | World Health Organization (WHO) | |
| 2025-521593-33 | Other Identifier | European Medical Agency (EMA) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
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| Sequence 2 | Experimental | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
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| Sequence 3 | Experimental | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
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| Sequence 4 | Experimental | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0363-1063 | Drug | NNC0363-1063 will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state | Measured in milligrams per kilogram (mg/kg). | Visit 2 and 3: Day 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| GIRmax,SS: Maximum glucose infusion rate at steady state | Measured in milligrams per kilogram*minute (mg/[kg*min]). | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Measured in hours. |
| 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). | 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). | 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. | Visit 2 and 3: Day 2 and 3 |
| Number of adverse events | Measured as number of events. | Visit 2 and 3: Day 2 and 3 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |