Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05352815 | A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec | PHASE3 | COMPLETED | 1,291 | — | — | Jun 1, 2022 | Apr 23, 2024 | Dec 4, 2025 | 281 | United States, Australia +20 |
| NCT05259033 | A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2) | PHASE3 | COMPLETED | 683 | — | — | Apr 11, 2022 | Jan 16, 2024 | Jul 9, 2025 | 136 | United States, Brazil +12 |
| NCT05013229 | A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3) | PHASE3 | COMPLETED | 679 | — | — | Nov 30, 2021 | Nov 14, 2023 | Dec 2, 2025 | 182 | United States, Czechia +12 |
| NCT05435677 | A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together | PHASE1 | COMPLETED | 20 | — | — | Jun 22, 2022 | Apr 25, 2023 | Mar 21, 2025 | 1 | China |
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.
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 | - |
| 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 | Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks. |
| 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 glargine | 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. |
| 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 |
Key inclusion criteria 1. Male or female and age above or equal to 18 years at the time of signing informed consent. 2. Diagnosed with type 2 diabetes mellitus 180 days or more before screening. 3. HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day...