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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
679
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.
Lakeview Clinical Research, LLC
Guntersville, Alabama, United States
Valley Research
Fresno, California, United States
Scripps Wht Diab Inst La Jolla
La Jolla, California, United States
Torrance Clin Res Inst, Inc.
Lomita, California, United States
Downtown LA Res Ctr. Inc.
Los Angeles, California, United States
Change in HbA1c
Percent-points
Time frame: From baseline week 0 (V2) to week 52 (V54)
Change in body weight
Kg
Time frame: From baseline week 0 (V2) to week 52 (V54)
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Number of episodes
Time frame: From week 0 (V52) to week 52 (V54)
Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Percentage of readings
Time frame: From week 48 (V50) to week 52 (V54)
Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Percentage of readings
Time frame: From week 48 (V50) to week 52 (V54)
Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Percentage of readings
Time frame: From week 48 (V50) to week 52 (V54)
Change in fasting plasma glucose (FPG)
mmol/L
Time frame: From baseline week 0 (V2) to week 52 (V54)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction
Score 0-36. The higher the score the greater the satisfaction with treatment.
Time frame: From baseline week 0 (V2) to week 52 (V54)
Number of severe hypoglycaemic episodes (level 3)
Number of episodes
Time frame: From baseline week 0 (V2) to week 57 (V56)
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Number of episodes
Time frame: From baseline week 0 (V2) to week 57 (V56)
Weekly insulin dose (total)
Units
Time frame: From week 50 (V52) to week 52 (V54)
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