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Active (not recruiting) Phase 3 NCT06534411

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

Phase 3 – large-scale trial before approval
Conditions: Diabetes Mellitus, Type 2

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
This 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.
Who can participate
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.
Locations 14
Argentina (1)
Centro Médico CIMEL
Lanús Este , Buenos Aires
Australia (1)
Paratus Clinical
Bruce , Australian Capital Territory
Brazil (1)
Centro de Diabetes Curitiba
Curitiba , Paraná
Canada (1)
Hilltop Medical Clinic
Surrey , British Columbia
Germany (1)
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen
Greece (1)
Alexandra General Hospital, Therapeutic Clinic
Athens , Attica
Hungary (1)
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
Szeged , Csongrád-Csanád
India (1)
Endolife Specialty Hospitals
Guntur , Andhra Pradesh
Israel (1)
Clalit sick fund Herzeliya
Herzeliya , Israel
Poland (1)
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok , Podlaskie Voivodeship
Romania (1)
Diabdana S.R.L.
Oradea , Bihor County
Spain (1)
Clinica Universitaria de Navarra
Pamplona , Navarre
Taiwan (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
United States (1)
Cahaba Research
Pelham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
05.11.2024
Completion date
14.07.2026
Registry ID
NCT06534411
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.