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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511808-17 | Other Identifier | European Medical Agency (EMA) | |
| U1111-1304-2544 | Other Identifier | World Health Organization (WHO) |
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This study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1 diabetes (T1D). This study part will last for about 1½ to 5½ weeks. Part 2 is a proof-of-principle (PoP) study part conducted in participants with T1D and will last for about 3½ to 8½ weeks. Part 3 is a meal test multiple dose study part conducted in participants with T1D and will last for 7 to 11 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: SAD: NNC0363-1063 | Experimental | Participants will receive single dose of NNC0363-1063 subcutaneously. |
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| Part 1A: SAD: Placebo | Placebo Comparator | Participants will receive NNC0363-1063 matching placebo subcutaneously. |
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| Part 1B: SAD: NNC0363-1063 | Experimental | Participants will receive NNC0363-1063 subcutaneously. |
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| Part 1B: SAD: Insulin degludec | Active Comparator | Participants will receive insulin degludec subcutaneously. |
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| Part 2: PoP: NNC0363-1063 | Experimental | Participants will receive NNC0363-1063 subcutaneously. |
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| Part 3 Meal test: NNC0363-1063 | Experimental | Participants will receive NNC0363-1063 subcutaneously. |
| 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 |
|---|---|---|
| Part 1 SAD: Number of adverse events | Measured in number of events. | From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8) |
| Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose | Measured in millilitre per hour*kilogram (mL/[h*kg]). | From IMP administration at day 1 up to 7 days |
| Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state | Measured in hours*millimoles per litre (h*mmol/L). | At day 2 of visit 2 and visit 3 after initiation of meal test |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 SAD: Number of hypoglycaemic episodes | Measured in number of episodes. | From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8) |
| Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose |
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Inclusion Criteria:
Part 1A SAD (healthy participants)
Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)
Exclusion Criteria:
Part 1A SAD (healthy participants)
Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)
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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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| ID | Term |
|---|---|
| C571886 | insulin degludec |
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Part 1 SAD and Part 3 Meal test are double-blind study parts. Sponsor staff involved in the clinical trial is masked according to company standard procedures. Part 2 is open-label study part.
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| Part 3 Meal test: Insulin detemir | Active Comparator | Participants will receive insulin detemir subcutaneously. |
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| Placebo | Drug | Placebo will be administered subcutaneously. |
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| Insulin degludec | Drug | Insulin degludec will be administered subcutaneously. |
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| Insulin detemir | Drug | Insulin detemir will be administered subcutaneously. |
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Measured in hours*picomoles per litre (h*pmol/L). |
| Up to 7 days |
| Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose | Measured in h*pmol/L. | Up to 2 days |
| Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose | Measured in picomoles per litre (pmol/L). | Up to 7 days |
| Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose | Measured in h*pmol/L. | Up to 7 days |
| Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose | Measured in h*pmol/L. | Up to 2 days |
| Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose | Measured in pmol/L. | Up to 7 days |
| Part 3 Meal test: AUC0-1h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 1 hour after initiation of the meal test at steady state | Measured in h*mmol/L. | From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3) |
| Part 3 Meal test: AUC0-2h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 2 hours after initiation of the meal test at steady state | Measured in h*mmol/L. | From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3) |
| Part 3 Meal test: AUC0-4h,PG,mean: Area under the plasma glucose concentration-time curve from 0 to 4 hours after initiation of the meal test at steady state | Measured in h*mmol/L. | From 0 hours to 4 hours after initiation of the meal test (day 2 of visit 2 and visit 3) |
| Part 3 Meal test: AUC0-6h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 6 hours after initiation of the meal test at steady state | Measured in h*mmol/L. | From 0 hours to 6 hours after initiation of the meal test (day 2 of visit 2 and visit 3) |
| Part 3 Meal test: PGmax,meal: Maximum observed plasma glucose concentration at steady state | Measured in millimoles per litre (mmol/L). | At day 2 of visit 2 and visit 3 after initiation of meal test |
| Part 3 Meal test: tPGmax,meal: Time to maximum observed plasma glucose concentration from at steady state | Measured in hours. | At day 2 of visit 2 and visit 3 after initiation of meal test |
| Part 3 Meal test: ΔPGav,0-1h,meal: Mean change in plasma glucose from 0 to 1 hour after initiation of the meal test at steady state | Measured in mmol/L. | From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3) |
| Part 3 Meal test: ΔPGav,0-2h,meal: Mean change in plasma glucose from 0 to 2 hours after initiation of the meal test at steady state | Measured in mmol/L. | From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3) |
| Part 3 Meal test: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state | Measured in h*pmol/L. | At day 2 of visit 2 and visit 3 after last IMP administration |
| Part 3 Meal test: Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state | Measured in pmol/L. | At day 2 of visit 2 and visit 3 after last IMP administration |
| Part 3 Meal test: Number of adverse events | Measured in number of events. | From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3) |
| Part 3 Meal test: Number of hypoglycaemic episodes | Measured in number of episodes. | From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |