NCT07112339
Recruiting
Phase 4
EFFectiveness of Once-weekly Insulin ICodec Versus Once-daily Basal Insulin Analogues in an Insulin-naïve Type 2 diabEtes Population in Real-world cliNical pracTice- The EFFICIENT Pragmatic Study Effectiveness of Insulin Icodec in Real-world Clinical Practice
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 586
- Locations
- 159
- Primary Endpoint
- Change in glycated haemoglobin (HbA1c)
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening.
- •Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening:
- •Metformin, Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist.
- •Need of intensification with basal insulin, as indicated at the discretion of the investigator.
- •Recorded HbA1c value ≥7% within the last 90 days prior to randomization.
Exclusion Criteria
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Previous participation in this study. Participation is defined as signed informed consent.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.
- •Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening.
- •Any disorder which in the investigator's opinion might jeopardize participant's safety.
Arms & Interventions
Basal insulin analogues
Active Comparator
Participants will receive once daily s.c. injection of basal insulin analogues.
Intervention: Basal insulin analogues (Drug)
Insulin icodec
Experimental
Participants will receive subcutaneous (s.c) injection of once weekly insulin icodec.
Intervention: Insulin icodec (Drug)
Outcomes
Primary Outcomes
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline week 0 to week 52
Measured as %-point.
Secondary Outcomes
- Adelphi Adherence Questionnaire (ADAQ©)(At week 52)
- Change in Diabetes Treatment Satisfaction Questionnaire- status version(DTSQs) total treatment satisfaction(From baseline week 0 to week 52)
- Treatment Related Impact Measure for Diabetes (TRIM-D) compliance domain(At week 52)
- Treatment Related Impact Measure for Diabetes (TRIM-D) treatment burden domain(At week 52)
- Number of severe hypoglycaemic episodes (level 3)(From baseline week 0 to week 52)
- Mean weekly basal insulin dose(From week 50 to week 52)
- Participant achieved individualised HbA1c target(At week 52)
Investigators
Study Sites (159)
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