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
Diabetes Mellitus, Type 2This 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.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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.
Study Location
G.A. Research Associates Ltd.
G.A. Research Associates Ltd.Moncton, New Brunswick
Canada
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Centricity Research Calgary
Centricity Research CalgaryCalgary, Alberta
Canada
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Medical Trust Clinics, Inc.
Medical Trust Clinics, Inc.Courtice, Ontario
Canada
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St. Josephs Health Care
St. Josephs Health CareLondon, Ontario
Canada
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The Ottawa Hospital_Riverside
The Ottawa Hospital_RiversideOttawa, Ontario
Canada
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Centricity Research Toronto Manna Multispec
Centricity Research Toronto Manna MultispecToronto, Ontario
Canada
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Centre hospitalier de l'Universite de Montreal
Centre hospitalier de l'Universite de MontrealMontreal, Quebec
Canada
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Centricity Res Pointe-Claire
Centricity Res Pointe-ClairePointe-Claire, Quebec
Canada
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Ctr de Med Metab de Lanaudiere
Ctr de Med Metab de LanaudiereTerrebonne, Quebec
Canada
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Fraser Clinical Trials Inc.
Fraser Clinical Trials Inc.New Westminster, British Columbia
Canada
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Centricity Clinical Research Burlington
Centricity Clinical Research BurlingtonBurlington, Ontario
Canada
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Janik Research
Janik ResearchGreater Sudbury, Ontario
Canada
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Malton Medical Clinic
Malton Medical ClinicMississauga, Ontario
Canada
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Sewa Ram Singal Medicine Professional Corp
Sewa Ram Singal Medicine Professional CorpToronto, Ontario
Canada
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Alpha Recherche Clinique - Clinique de Levis
Alpha Recherche Clinique - Clinique de LevisLévis, Quebec
Canada
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Applied Medical Informatics Research
Applied Medical Informatics ResearchMontreal, Quebec
Canada
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Centre de Recherche Saint-Louis
Centre de Recherche Saint-LouisSherbrooke, Quebec
Canada
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Diex Recherche Victoriaville
Diex Recherche VictoriavilleVictoriaville, Quebec
Canada
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Winnipeg Clinic
Winnipeg ClinicWinnipeg, Manitoba
Canada
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Centricity Research Vaughn Endocrinology
Centricity Research Vaughn EndocrinologyConcord, Ontario
Canada
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Premier Clinical Trial Research Network (PCTRN)
Premier Clinical Trial Research Network (PCTRN)Hamilton, Ontario
Canada
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Centricity Research Ottawa LMC
Centricity Research Ottawa LMCNepean, Ontario
Canada
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Centricity Research Toronto
Centricity Research TorontoToronto, Ontario
Canada
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Centricity Research Mirabel
Centricity Research MirabelMirabel, Quebec
Canada
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Clinique Endocrinologie OASIS.
Clinique Endocrinologie OASIS.Montreal, Quebec
Canada
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Diex Recherche Sherbrooke Inc.
Diex Recherche Sherbrooke Inc.Sherbrooke, Quebec
Canada
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Alta Clinical Research at Hermitage Medicentre
Alta Clinical Research at Hermitage MedicentreEdmonton, Alberta
Canada
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Centricity Research Brampton
Centricity Research BramptonBrampton, Ontario
Canada
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Centricity Research Etobicoke
Centricity Research EtobicokeEtobicoke, Ontario
Canada
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Western Univ. Cnt for Studies in Fam Med
Western Univ. Cnt for Studies in Fam MedLondon, Ontario
Canada
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Bluewater Clin Res Group Inc
Bluewater Clin Res Group IncSarnia, Ontario
Canada
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Diex Recherche Joliette
Diex Recherche JolietteJoliette, Quebec
Canada
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McGill University Health Centre
McGill University Health CentreMontreal, Quebec
Canada
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ALPHA Recherche Clinique
ALPHA Recherche CliniqueQuébec, Quebec
Canada
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Diex Recherche Trois-Rivieres
Diex Recherche Trois-RivieresTrois-Rivières, Quebec
Canada
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Alpha Recherche Clinique - Lebourgneuf
Alpha Recherche Clinique - LebourgneufQuébec, Quebec
Canada
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Centre de Recherche Saint-Louis
Centre de Recherche Saint-LouisQuébec, Quebec
Canada
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Diex Recherche Quebec Inc.
Diex Recherche Quebec Inc.Québec, Quebec
Canada
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Recherche Clinique Sigma Inc.
Recherche Clinique Sigma Inc.Québec, Quebec
Canada
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Centricity Research Calgary Endocrinology
Centricity Research Calgary EndocrinologyCalgary, Alberta
Canada
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Centricity Research Brampton Endocrinology
Centricity Research Brampton EndocrinologyBrampton, Ontario
Canada
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Centricity Research Etobicoke Endocrinology
Centricity Research Etobicoke EndocrinologyEtobicoke, Ontario
Canada
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Diex Recherche Sherbrooke Inc.
Diex Recherche Sherbrooke Inc.Sherbrooke, Quebec
Canada
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- Study Sponsored By
- Novo Nordisk A/S
- Participants Required
- More Information
- Study ID:
NCT07112339