A Research Study to See How Much CagriSema (1.0 mg Once Weekly) Lowers Blood Sugar and Body Weight Compared to Tirzepatide (5 mg Once Weekly) in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Diabetes Mellitus, Type 2This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.
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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) \>= 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
* sodium-glucose co-transporter 2 inhibitor (SGLT2i)
* Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
* Body mass index (BMI) \>= 30 kilogram per square meter (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:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
* Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
* Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is 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. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Lieu de l'étude
Hilltop Medical Clinic
Hilltop Medical ClinicSurrey, British Columbia
Canada
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Wharton Med Clin Trials
Wharton Med Clin TrialsHamilton, Ontario
Canada
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Alpha Recherche Clinique - Clinique de Levis
Alpha Recherche Clinique - Clinique de LevisLevis, Quebec
Canada
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Centricity Research Etobicoke
Centricity Research EtobicokeEtobicoke, Ontario
Canada
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Ctr de rech Clin de Laval
Ctr de rech Clin de LavalLaval, Quebec
Canada
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Diex Recherche Victoriaville
Diex Recherche VictoriavilleVictoriaville, Quebec
Canada
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G.A. Research Associates Ltd.
G.A. Research Associates Ltd.Moncton, New Brunswick
Canada
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London Road Diagnostic Clinic and Medical Centre
London Road Diagnostic Clinic and Medical CentreSarnia, Ontario
Canada
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Centre Medical Acadie
Centre Medical AcadieMontreal, Quebec
Canada
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Centricity Research Brampton
Centricity Research BramptonBrampton, 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:
NCT06534411