Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0363-0845 · 2 trials · 2 indications
messured in h\*mmol/L
Number of events
| Arm | Type | Description |
|---|---|---|
| NNC0363-0845 followed by insulin detemir | EXPERIMENTAL | Participants will get subcutaneous (under the skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of insulin detemir up to 6 times daily for 3 days. |
| Insulin detemir followed by NNC0363-0845 | EXPERIMENTAL | Participants will get subcutaneous (under the skin) injections of insulin detemir up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of NNC0363-0845 (study medicine) up to 6 times daily for 3 days. |
| Part 1 | EXPERIMENTAL | Healthy volunteers will receive either NNC0363-0845 or placebo |
| Part 2 | EXPERIMENTAL | Participants with T1D will receive either NNC0363-0845 or insulin degludec |
| Part 3 | EXPERIMENTAL | Participants with T1D will receive NNC0363-0845 |
| Name | Type | Description |
|---|---|---|
| NNC0363-0845 | DRUG | Participants will receive 0.5 nmol/kg NNC0363-0845 s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 3 nmol/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks |
| Insulin detemir | DRUG | Participants will receive 0.083 U/kg insulin detemir s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 0.5 U/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks |
| Placebo (NNC0363-0845) | DRUG | A single dose administered s.c. |
| Insulin degludec | DRUG | A single dose administered s.c. |
Key inclusion criteria: * Male participant or female participant of non-childbearing 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 m...
NNC0363-0845 is an investigational small molecule being studied for the treatment of Type 1 Diabetes Mellitus. It has been evaluated in healthy volunteers and in people with Type 1 Diabetes to assess its safety, pharmacokinetics, and pharmacodynamics. The drug is administered subcutaneously and is currently in Phase 1 clinical development.
NNC0363-0845 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the safety and effects of this investigational drug in healthy volunteers and in patients with Type 1 Diabetes.
NNC0363-0845 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one involving healthy volunteers and people with Type 1 Diabetes, and another in participants with Type 1 Diabetes. The drug is investigational and has not been approved by regulatory authorities.
NNC0363-0845 has been studied in two completed Phase 1 trials. The first, NCT04569994, evaluated safety in healthy people and those with Type 1 Diabetes in Germany. The second, NCT05134987, investigated pharmacokinetics and pharmacodynamics of subcutaneous dosing in participants with Type 1 Diabetes in Austria.
NNC0363-0845 is an insulin drug, as indicated by the trial title describing how it is transported throughout the body and how it works. It is administered subcutaneously and is being studied for its effects in people with Type 1 Diabetes. The specific molecular target is not disclosed in the available information.