Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IcoSema · 5 trials · 2 indications
Measured in percentage (%)-point.
Change from baseline (week 0) to week 52 in HbA1c is presented.The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.
Percent-points
Measured in hours\*pmol/L
Measured in (hours\*nmol/L)/mg
| Arm | Type | Description |
|---|---|---|
| IcoSema | EXPERIMENTAL | Participants will receive once weekly IcoSema subcutaneously with or without oral anti diabetic drugs for 40 weeks. |
| Insulin glargine | EXPERIMENTAL | Participants will receive once daily insulin glargine subcutaneously with or without oral anti diabetic drugs for 40 weeks. |
| Insulin icodec | ACTIVE_COMPARATOR | - |
| Semaglutide | EXPERIMENTAL | Participants will get once weekly dose |
| Insuling glargine/insulin aspart | ACTIVE_COMPARATOR | Participants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart. |
| Sequence 1 | EXPERIMENTAL | All participants will get each of the 3 medicines at 3 different timepoints IcoSema - insulin icodec - semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
| Sequence 2 | EXPERIMENTAL | All participants will get each of the 3 medicines at 3 different timepoints IcoSema- semaglutide . insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
| Sequence 3 | EXPERIMENTAL | All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- IcoSema- semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
| Sequence 4 | EXPERIMENTAL | All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- semaglutide - IcoSema separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
| Sequence 5 | EXPERIMENTAL | All participants will get each of the 3 medicines at 3 different timepoints semaglutide - IcoSema - insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
| Sequence 6 | EXPERIMENTAL | All participants will get each of the 3 medicines at 3 different timepoints semaglutide - insulin icodec - IcoSema, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
| Name | Type | Description |
|---|---|---|
| IcoSema | DRUG | IcoSema will be administered subcutaneously. |
| Insulin glargine | DRUG | Insulin glargine will be administered subcutaneously. |
| Insulin icodec | DRUG | Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks. |
| Semaglutide 1 mg | DRUG | Semaglutide once weekly subcutaneously (s.c., under the skin). Dose titrated to 1mg over 8 weeks (0.25 mg for 4 weeks, 0.5 mg for 4 weeks). For about 1 year and 1 month. |
| insulin aspart | DRUG | Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks. |
| semaglutide | DRUG | One single dose of semaglutide administered subcutaneously, S.c. into the left thigh |
Inclusion Criteria: * Male or female and age above or equal to 18 years at the time of signing the informed consent. * Diagnosed with T2D greater than or equal to (≥) 180 days before screening. * HbA1c ≥ 8.0% (≥ 64.0 millimoles per mole \[mmol/mol\]) as assessed by central laboratory on the day of ...
IcoSema is an investigational combination of insulin icodec and semaglutide, developed for the treatment of Type 2 Diabetes Mellitus. It is designed to control blood sugar levels in adults with Type 2 Diabetes. IcoSema is administered weekly and is currently in Phase 3 clinical development.
IcoSema combines insulin icodec, a long-acting basal insulin, with semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. This dual mechanism aims to improve glycemic control by providing both insulin replacement and enhancing glucose-dependent insulin secretion, while also suppressing glucagon release and slowing gastric emptying.
IcoSema is being developed by Novo Nordisk A/S, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVO. Novo Nordisk is conducting Phase 3 clinical trials to evaluate the efficacy and safety of IcoSema in people with Type 2 Diabetes.
IcoSema is in Phase 3 clinical development. It is not yet approved by regulatory authorities and remains an investigational medicine. Four clinical trials have been completed, including three Phase 3 studies and one Phase 1 study, with a total enrollment of 2,673 participants.
IcoSema has completed four clinical trials. The Phase 3 trials include NCT05013229 (COMBINE 3), comparing IcoSema to insulin glargine plus insulin aspart; NCT05259033 (COMBINE 2), comparing IcoSema to semaglutide; and NCT05352815, comparing IcoSema to insulin icodec. A Phase 1 trial, NCT05435677, studied the pharmacokinetics in Chinese participants.
IcoSema is a fixed combination of insulin icodec and semaglutide, but it is not the same as either component alone. Insulin icodec is a once-weekly basal insulin, and semaglutide is a once-weekly GLP-1 receptor agonist. IcoSema combines both into a single weekly injection for Type 2 Diabetes.