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Diabetes

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)

Locations

Brazil, Canada, China, France, Greece, Hungary, Israel, Japan, Russia, Slovakia, Sweden, Switzerland, Taiwan, United States

Start date

11/04/2022

Trial ID
NN1535-4592

NCT number
NCT05259033

Eudract number
2020 005308 21

Summary

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide.

Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach.

The study will last for about 1 year and 1 month. Participants will have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls. At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Trial Overview:

Condition

Diabetes Mellitus

Type 2

Treatment

Drug: IcoSema

Drug: Semaglutide 1 mg

Study type

Interventional

Trial duration

Apr 11 2022 - Feb 17 2024

Participation duration

Unknown

Phase

III

Are you eligible?

Gender

Male and female

Age

18+ years old

Questions or concerns

Do you have any question about what it’s like being a clinical volunteer? Have a look at our answers to frequently asked questions.

This site contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of a healthcare professional and should not be construed as providing advice or making a recommendation. The information on this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific product is correct for a particular patient. If you have questions regarding any information contained on this site you should consult a physician.