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 developed by Novo Nordisk A/S for the treatment of type 1 diabetes mellitus. It has been studied in Phase 1 clinical trials, including a multiple dose study of subcutaneous administration in participants with type 1 diabetes. It is not an approved therapy.
NNC0363-0845 is being developed as a treatment for type 1 diabetes mellitus. Clinical testing has focused on how the subcutaneous formulation is transported through the body and how it works in adults with the condition, as well as its safety profile in healthy volunteers and people with type 1 diabetes.
NNC0363-0845 is developed by Novo Nordisk A/S, the Danish pharmaceutical company whose shares trade under the ticker NVO. Novo Nordisk sponsored both Phase 1 trials of the compound, one conducted in Austria and one in Germany.
NNC0363-0845 is in Phase 1 development. Both of its clinical trials have been completed, and no trials are currently active. It is an investigational small molecule and has not been approved by the FDA for any indication.
NNC0363-0845 has been evaluated in two completed Phase 1 trials. NCT05134987 was a multiple dose study of subcutaneous NNC0363-0845 in 30 participants with type 1 diabetes in Austria. NCT04569994 assessed safety in 68 healthy volunteers and people with type 1 diabetes in Germany.
The two completed Phase 1 trials of NNC0363-0845 enrolled a total of 98 participants. NCT04569994 enrolled 68 healthy volunteers and people with type 1 diabetes, while NCT05134987 enrolled 30 participants with type 1 diabetes. Both studies were randomized, double-blind, and controlled.