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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05262595 | A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump | PHASE1 | COMPLETED | 19 | — | — | Mar 3, 2022 | Sep 5, 2022 | Oct 12, 2023 | 1 | Austria |
Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours). Measured in percentage
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
| Arm 2 | EXPERIMENTAL | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
| Arm 3 | EXPERIMENTAL | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
| Arm 4 | ACTIVE_COMPARATOR | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
| Name | Type | Description |
|---|---|---|
| NNC0471-0119 A | DRUG | NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months |
| NNC0471-0119 B | DRUG | NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months |
| NNC0471-0119 D | DRUG | NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months |
| Faster aspart | DRUG | Faster aspart administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months |
Inclusion Criteria: * Male participant or female participant of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months...