This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
877
Insulin icodec will be administered as subcutaneous injection
Insulin glargine will be administered as subcutaneous injection.
Insulin aspart will be administered as a subcutaneous injection.
Cullman Clinical Trials
Cullman, Alabama, United States
John Muir Health
Concord, California, United States
Headlands Research California, LLC
Escondido, California, United States
Clinical Res of Central Ca
Fresno, California, United States
Providence Medical Foundation
Fullerton, California, United States
Change in glycosylated haemoglobin (HbA1c)
Measured in percentage (%)-points.
Time frame: From baseline (week 0) to week 26
Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))
Measured in %-points.
Time frame: From baseline (week-2-0) to week 22-26
Time spent less than (<)3.0 mmol/L (54 mg/dL)
Measured in % of time.
Time frame: From week 22 to week 26
Change in time spent greater than (>)10.0 mmol/L (180 mg/dL)
Measured in %-points.
Time frame: From baseline (week-2-0) to week 22-26
Number of severe hypoglycaemic episodes (level 3)
Measured as number of episodes.
Time frame: From baseline (week 0) to week 31
Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter)
Measured as number of episodes.
Time frame: From baseline (week 0) to week 31
Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3)
Measured as number of episodes.
Time frame: From baseline (week 0) to week 31
Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL])
Measured as number of episodes.
Time frame: From baseline (week 0) to week 31
Mean total weekly insulin dose
Measured in insulin units.
Time frame: From week 24 to week 26
Change in body weight
Measured in Kilogram (kg).
Time frame: From baseline (week 0) to week 26
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Scripps Whittier Diabetes Inst
La Jolla, California, United States
Loma Linda University Faculty Medical Clinics
Loma Linda, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Los Angeles Institute for Metabolic Research
Los Angeles, California, United States
Pasadena Clinical Trials
Pasadena, California, United States
...and 172 more locations