Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Insulin 320 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Level 1-7 escalating doses | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Insulin 320 | DRUG | Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation. |
| insulin glargine | DRUG | As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels. |
| placebo | DRUG | Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels. |
Inclusion Criteria: * Male, aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index 18.5-28.0 kg/m\^2 (both inclusive) * Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms...
Insulin 320 is an investigational small molecule drug being developed by Novo Nordisk A/S for diabetes. It is designed as an agonist of the insulin receptor (INSR). The compound has completed a Phase 1 clinical trial in healthy male subjects, and it has not been approved by the FDA.
Insulin 320 targets the insulin receptor, also known as INSR. It acts as an agonist at this receptor, meaning it activates insulin receptor signaling. This mechanism is intended to support glucose control in diabetes. The target class is an agonist, and the drug is a small molecule.
Insulin 320 is being developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program for this investigational diabetes candidate.
Insulin 320 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
Insulin 320 has been studied in one completed Phase 1 trial, NCT02479022. The trial investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of Insulin 320 in healthy subjects. It enrolled 84 participants in Germany and was randomized and double-blind.
Insulin 320 is being investigated for the treatment of diabetes. The completed Phase 1 trial included participants with type 2 diabetes and healthy volunteers. It is an investigational therapy and is not approved for use in diabetes or any other condition.