Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fast-acting insulin aspart · 1 trial · 1 indication
Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL \[3 mmol/L\]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.
Interstitial glucose: glucose measured in interstitial fluid. Time in low interstitial glucose (defined as below 54 mg/dL \[3 mmol/L\]) from initiation of treatment (day 1) to end of treatment (day 7). Time spent in low interstitial glucose is calculated as the percentage of available interstitial glucose values below the threshold.
| Arm | Type | Description |
|---|---|---|
| Fast-acting insulin aspart, default tmax setting | EXPERIMENTAL | Participants will receive fast-acting insulin aspart using the iLet™ with default tmax setting (t65 = 65 minutes) in two different treatment periods in a cross-over manner. There will be 3 different cohorts with 2 treatment periods in each cohort. |
| Fast-acting insulin aspart, non-default tmax setting | EXPERIMENTAL | Participants will receive fast-acting insulin aspart using the iLet™ with non-default tmax setting (t50 = 50 minutes, t40 = 40 minutes or t30 = 30 minutes) in two different treatment periods in a cross-over manner. There will be 3 different cohorts with 2 treatment periods in each cohort. |
| Name | Type | Description |
|---|---|---|
| Fast-acting insulin aspart | DRUG | In each cohort, participants will receive fast-acting insulin aspart using the iLet™ in a cross-over manner for 14 days (7days per period). Dose modification will be handled autonomously by the iLet™ based on the CGM sensor readings and the user interaction with the iLet™ e.g. meal announcements. |
| iLet™ | DEVICE | The bionic pancreas including pigtail adapters, used in insulin-only configuration |
Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, age more than or equal to 18 years and less than ...
Fast-acting insulin aspart is an investigational small molecule being studied for the treatment of Type 1 Diabetes Mellitus. It is designed to be used with an insulin pump system to manage blood glucose levels in adults with this condition.
Fast-acting insulin aspart is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the stock exchange under the ticker symbol NVO.
Fast-acting insulin aspart is currently in Phase 2 of clinical development. It is an investigational drug and has not yet been approved by regulatory authorities for commercial use.
Fast-acting insulin aspart has been studied in one completed Phase 2 clinical trial, identified as NCT03816761. This trial examined the drug's use with the iLet insulin pump system in adults with Type 1 Diabetes Mellitus in the United States.
Fast-acting insulin aspart is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial, but it remains in clinical development and has not received regulatory approval for marketing.