Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07305805 | A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes | PHASE1 | COMPLETED | 36 | — | — | Dec 16, 2025 | May 8, 2026 | Jun 5, 2026 | 1 | Germany |
| NCT06685185 | A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes | PHASE1 | COMPLETED | 117 | — | — | Nov 12, 2024 | Mar 18, 2026 | Apr 9, 2026 | 1 | Germany |
Measured in milligrams per kilogram (mg/kg).
Measured in number of events.
Measured in millilitre per hour\*kilogram (mL/\[h\*kg\]).
Measured in hours\*millimoles per litre (h\*mmol/L).
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Sequence 2 | EXPERIMENTAL | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Sequence 3 | EXPERIMENTAL | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Sequence 4 | EXPERIMENTAL | Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2. |
| Part 1A: SAD: NNC0363-1063 | EXPERIMENTAL | Participants will receive single dose of NNC0363-1063 subcutaneously. |
| Part 1A: SAD: Placebo | PLACEBO_COMPARATOR | Participants will receive NNC0363-1063 matching placebo subcutaneously. |
| Part 1B: SAD: NNC0363-1063 | EXPERIMENTAL | Participants will receive NNC0363-1063 subcutaneously. |
| Part 1B: SAD: Insulin degludec | ACTIVE_COMPARATOR | Participants will receive insulin degludec subcutaneously. |
| Part 2: PoP: NNC0363-1063 | EXPERIMENTAL | Participants will receive NNC0363-1063 subcutaneously. |
| Part 3 Meal test: NNC0363-1063 | EXPERIMENTAL | Participants will receive NNC0363-1063 subcutaneously. |
| Part 3 Meal test: Insulin detemir | ACTIVE_COMPARATOR | Participants will receive insulin detemir subcutaneously. |
| Name | Type | Description |
|---|---|---|
| NNC0363-1063 | DRUG | NNC0363-1063 will be administered subcutaneously. |
| Placebo | DRUG | Placebo will be administered subcutaneously. |
| Insulin degludec | DRUG | Insulin degludec will be administered subcutaneously. |
| Insulin detemir | DRUG | Insulin detemir will be administered subcutaneously. |
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 ...