Last updated 3 days ago
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
1000 patients around the world
Available in Spain, Brazil, Argentina, United States
Novo Nordisk A/S
10Research sites
1000Patients around the world
This study is for people with
Diabetes
Diabetes mellitus type 2
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Male or female.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.
- 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 a fundus 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.
Sites
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
Instituto de Investigaciones Clínicas San Nicolás
Recruiting
Clínica de Fracturas y Ortopedia
Recruiting
Fundación Centro de Salud e Investigaciones Médicas (CESIM)
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
Investigaciones Médicas IMOBA SRL
Recruiting
Centro Médico Cimel Chahin Chahin S.A.
Recruiting
Centro de Diabetes Curitiba - Curitiba, Parana
Recruiting
Núcleo de Pesquisa Clínica do Rio Grande do Sul - NPCRS
Recruiting
CPQuali Pesquisa Clínica
Recruiting
StudyREIMAGINE 5
SponsorNovo Nordisk A/S
Conditions
Diabetes mellitus type 2
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06534411
