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
NCT05435677 · Completed
Last updated 2026-05-28This study is testing how two diabetes medications, insulin icodec and semaglutide, work in the bodies of people from China who have type 2 diabetes when taken alone or together.
What this study is testing ClinicalTrials.gov NCT05435677 ↗
Description as written by the study sponsor.
This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes. IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide. Insulin icodec is a possible new medicine. That means that the medicine has not yet been approved by the authorities. Semaglutide is a medicine already approved by the authorities in the EU, USA, China and Japan. The study will look at the way insulin icodec and semaglutide reach and stay in participants blood after injection when given together as IcoSema or alone as insulin icodec and semaglutide. Participants will get each of the 3 medicines (IcoSema, insulin icodec and semaglutide) at 3 different timepoints: The order in which participants get them is decided by chance. Participants will get the 3 medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks. The study will last for about 19 to 26 weeks. Participants will have 31 or 32 visits to the clinic. 3 of the visits will be in-house visits, meaning that participants will stay at the clinic for 5 or 6 days (4 or 5 nights). Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Treatments tested
- IcoSema Drug
One single dose of IcoSema administered subcutaneously, S.c. into the left thigh
- insulin icodec Drug
One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh
- semaglutide Drug
One single dose of semaglutide administered subcutaneously, S.c. into the left thigh
| Main thing measured | AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Conditions studied | Diabetes Mellitus, Type 2 |
| GLP-1 drugs | semaglutide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05435677 ↗