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RECRUITINGPhase 4INTERVENTIONAL

A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Known or suspected hypersensitivity to study intervention(s) or related products. - Previous participation in this study. Participation is defined as signed willing to sign a consent form. - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Insulin icodec

Insulin icodec will be administered as subcutaneous injection.

DRUG

Basal insulin analogues

Basal insulin analogues will be administered as subcutaneous injection.

Locations (20)

Centricity Research Calgary Endocrinology
Calgary, Alberta, Canada
Alta Clinical Research at Hermitage Medicentre
Edmonton, Alberta, Canada
Fraser Clinical Trials Inc.
New Westminster, British Columbia, Canada
Winnipeg Clinic
Winnipeg, Manitoba, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, Canada
Centricity Clinical Research Burlington
Burlington, Ontario, Canada
Centricity Research Vaughn Endocrinology
Concord, Ontario, Canada
Medical Trust Clinics, Inc.
Courtice, Ontario, Canada
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, Canada
Janik Research
Greater Sudbury, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
St. Josephs Health Care
London, Ontario, Canada
Western Univ. Cnt for Studies in Fam Med
London, Ontario, Canada
Malton Medical Clinic
Mississauga, Ontario, Canada
Centricity Research Ottawa LMC
Nepean, Ontario, Canada
The Ottawa Hospital_Riverside
Ottawa, Ontario, Canada
Bluewater Clin Res Group Inc
Sarnia, Ontario, Canada
Sewa Ram Singal Medicine Professional Corp
Toronto, Ontario, Canada
Centricity Research Toronto
Toronto, Ontario, Canada