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
RECRUITINGJohn Muir Health
Concord, California, United States
RECRUITINGHeadlands Research California, LLC
Escondido, California, United States
RECRUITINGClinical Res of Central Ca
Fresno, 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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Providence Medical Foundation
Fullerton, California, United States
RECRUITINGScripps Whittier Diabetes Inst
La Jolla, California, United States
RECRUITINGLoma Linda University Faculty Medical Clinics
Loma Linda, California, United States
RECRUITINGLoma Linda University Faculty Medical Clinics
Loma Linda, California, United States
NOT_YET_RECRUITINGPacific Clinical Studies
Los Alamitos, California, United States
RECRUITINGPasadena Clinical Trials
Pasadena, California, United States
RECRUITING...and 174 more locations