This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
485
IcoSema will be administered subcutaneously.
Insulin glargine will be administered subcutaneously.
Univ of Alabama_Birmingham
Birmingham, Alabama, United States
John Muir Physicians Network
Concord, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
First Valley Med Grp Lancaster
Lancaster, California, United States
Clinical Trials Research_Sacramento
Lincoln, California, United States
Change in glycated haemoglobin (HbA1c)
Measured in percentage (%)-point.
Time frame: From baseline (week 0) to week 40
Change in body weight
Measured in kilogram (kg).
Time frame: From baseline (week 0) to week 40
Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL])
Measured in % of readings.
Time frame: From week 36 to week 40
Time spent less than (<) 3.0 mmol/L (54 mg/dL)
Measured in % of readings.
Time frame: From week 36 to week 40
Time spent greater than (>) 10.0 mmol/L (180 mg/dL)
Measured in % of readings.
Time frame: From week 36 to week 40
Weekly basal insulin dose
Measured in units of insulin.
Time frame: From week 38 to week 40
Change in fasting plasma glucose (FPG)
Measured in mmol/l.
Time frame: From baseline (week 0) to week 40
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction
The DTSQs items are scored on a 7-point graded response scale ranging from 0 to 6. Score ranges from 0 to 36. Higher scores indicate greater the satisfaction with medication.
Time frame: From baseline (week 0) to week 40
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3)
Measured in number of episodes.
Time frame: From baseline (week 0) to week 45
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Measured in number of episodes.
Time frame: From baseline (week 0) to week 45
Number of severe hypoglycaemic episodes (level 3)
Measured in number of episodes.
Time frame: From baseline (week 0) to week 45
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Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Northeast Research Institute
Fleming Island, Florida, United States
East Coast Institute For Research
Jacksonville, Florida, United States
Clinical Research of Cent FL
Winter Haven, Florida, United States
...and 108 more locations