IcoSema
DrugParticipants will receive a once weekly subcutanous (s.c.) injection of IcoSema, on the same day every week for 52 weeks.
NCT Number: NCT05013229
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart 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 insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries.
Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines 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 be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study.
Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Fakultni nemocnice Plzen, Pilsen, Czech Republic, Czechia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a once weekly subcutanous (s.c.) injection of IcoSema, on the same day every week for 52 weeks.
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.
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.
Time frame: From baseline week 0 (V2) to week 52 (V54)
Percent-points
Time frame: From baseline week 0 (V2) to week 52 (V54)
Kg
Time frame: From week 0 (V52) to week 52 (V54)
Number of episodes
Time frame: From week 48 (V50) to week 52 (V54)
Percentage of readings
Time frame: From week 48 (V50) to week 52 (V54)
Percentage of readings
Time frame: From week 48 (V50) to week 52 (V54)
Percentage of readings
Time frame: From baseline week 0 (V2) to week 52 (V54)
mmol/L
Time frame: From baseline week 0 (V2) to week 52 (V54)
Score 0-36. The higher the score the greater the satisfaction with treatment.
Time frame: From baseline week 0 (V2) to week 57 (V56)
Number of episodes
Time frame: From baseline week 0 (V2) to week 57 (V56)
Number of episodes
Time frame: From week 50 (V52) to week 52 (V54)
Units
Novo Nordisk A/S
Industry
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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