Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IGlar U100 · 1 trial · 1 indication
Measured in pmol\*h/L
| Arm | Type | Description |
|---|---|---|
| Insulin 287 followed by insulin glargine U100 | EXPERIMENTAL | Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised. After run-in, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling where subjects are treated with once daily (OD) insulin glargine. After insulin 287 treatment, participants will receive insulin glargine U100 OD for 2 weeks. |
| Insulin glargine U100 followed by insulin 287 | EXPERIMENTAL | Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised. After run-in, participants will receive insulin glargine U100 OD for 2 weeks followed by 1-14 days (at least 1 day is mandatory) of continued insulin glargine treatment. After insulin glargine treatment, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling. |
| Name | Type | Description |
|---|---|---|
| Insulin icodec | DRUG | Participants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks |
| IGlar U100 | DRUG | Participants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks. |
Inclusion Criteria: * Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening * Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day * Bod...
IGlar U100 is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
IGlar U100 is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker symbol NVO.
IGlar U100 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use. One Phase 1 trial has been completed.
IGlar U100 has one completed clinical trial, registered as NCT03723772. This Phase 1 study, titled 'A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week', enrolled 66 participants in Germany.
IGlar U100 is also known as Insulin 287, as referenced in the clinical trial title for study NCT03723772. The trial evaluates the effects of this medicine on blood sugar in people with Type 1 Diabetes.