This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes. The study will last for about 13 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
586
Insulin icodec will be administered as subcutaneous injection.
Basal insulin analogues will be administered as subcutaneous injection.
Centricity Research Calgary Endocrinology
Calgary, Alberta, Canada
RECRUITINGAlta Clinical Research at Hermitage Medicentre
Edmonton, Alberta, Canada
RECRUITINGFraser Clinical Trials Inc.
New Westminster, British Columbia, Canada
RECRUITINGWinnipeg Clinic
Winnipeg, Manitoba, Canada
Change in glycated haemoglobin (HbA1c)
Measured as %-point.
Time frame: From baseline week 0 to week 52
Adelphi Adherence Questionnaire (ADAQ©)
Measured as Score. The ADAQ© score is calculated as the mean of 11 individual items, each rated on a scale from 0 to 4. To obtain the mean score, at least 8 of these items must be answered. A lower score indicates greater adherence.
Time frame: At week 52
Change in Diabetes Treatment Satisfaction Questionnaire- status version(DTSQs) total treatment satisfaction
Measured as Score of 0-36. DTSQs score ranges from 0 to 36, based on 6 items that are each rated on a scale of 0 to 6. A higher score reflects greater satisfaction with the treatment received.
Time frame: From baseline week 0 to week 52
Treatment Related Impact Measure for Diabetes (TRIM-D) compliance domain
Measured as Score of 4-20.The score ranges from 4 to 20, based on 4 items rated on a scale of 1 to 5. This score is then transformed to a 0-100 scale, where higher scores indicate better compliance.
Time frame: At week 52
Treatment Related Impact Measure for Diabetes (TRIM-D) treatment burden domain
Measured as Score of 6-30. The score ranges from 6 to 30, derived from 6 items each rated on a scale of 1 to 5. This score is then transformed to a 0-100 scale, where higher scores indicate less treatment burden.
Time frame: At week 52
Number of severe hypoglycaemic episodes (level 3)
Measured as Number of episodes.
Time frame: From baseline week 0 to week 52
Mean weekly basal insulin dose
Measures in Units.
Time frame: From week 50 to week 52
Participant achieved individualised HbA1c target
Reported as Yes or No.
Time frame: At week 52
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G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
RECRUITINGCentricity Research Brampton Endocrinology
Brampton, Ontario, Canada
RECRUITINGCentricity Clinical Research Burlington
Burlington, Ontario, Canada
COMPLETEDCentricity Research Vaughn Endocrinology
Concord, Ontario, Canada
RECRUITINGMedical Trust Clinics, Inc.
Courtice, Ontario, Canada
COMPLETEDCentricity Research Etobicoke Endocrinology
Etobicoke, Ontario, Canada
RECRUITING...and 65 more locations