A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
Type 2 Diabetes MellitusThe study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
Inclusion Criteria:
* Male or female (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.
* Stable daily dose(s) greater than or equal to 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.
* Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
* Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
Exclusion Criteria:
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by central laboratory at screening.
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation.
Lieu de l'étude
Ocean West Research Clinic
Ocean West Research ClinicSurrey, British Columbia
Canada
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Centricity Res. Barrie Endo
Centricity Res. Barrie EndoBarrie, Ontario
Canada
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Centricity Research Etobicoke
Centricity Research EtobicokeEtobicoke, Ontario
Canada
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Centricity Research Oshawa
Centricity Research OshawaOshawa, Ontario
Canada
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Centricity Res Pointe-Claire
Centricity Res Pointe-ClairePointe-Claire, Quebec
Canada
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TLC Diabetes and Endocrinology
TLC Diabetes and EndocrinologySurrey, British Columbia
Canada
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G.A. Research Associates Ltd.
G.A. Research Associates Ltd.Moncton, New Brunswick
Canada
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Medical Trust Clinics, Inc.
Medical Trust Clinics, Inc.Courtice, Ontario
Canada
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Centricity Research Ottawa LMC
Centricity Research Ottawa LMCNepean, Ontario
Canada
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Centre Medical Acadie
Centre Medical AcadieMontreal, Quebec
Canada
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Diex Recherche Victoriaville
Diex Recherche VictoriavilleVictoriaville, Quebec
Canada
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Centricity Research Calgary
Centricity Research CalgaryCalgary, Alberta
Canada
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Hilltop Medical Clinic
Hilltop Medical ClinicSurrey, British Columbia
Canada
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Centricity Research Brampton
Centricity Research BramptonBrampton, Ontario
Canada
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Milestone Research
Milestone ResearchLondon, Ontario
Canada
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Centricity Research Toronto
Centricity Research TorontoToronto, Ontario
Canada
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ALPHA Recherche Clinique
ALPHA Recherche CliniqueQuebec City, Quebec
Canada
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Guilford Med Clinic
Guilford Med ClinicSurrey, British Columbia
Canada
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Spectrum Health Clinic
Spectrum Health ClinicVancouver, British Columbia
Canada
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Centricity Research Vaughn
Centricity Research VaughnConcord, 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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Diabetes Heart Research Centre
Diabetes Heart Research CentreToronto, Ontario
Canada
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Ctr de Med Metab de Lanaudiere
Ctr de Med Metab de LanaudiereTerrebonne, Quebec
Canada
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- Étude parrainée par
- Novo Nordisk A/S
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06065540