Last updated 19 days ago
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
7000 patients around the world
Available in Argentina, Mexico, United States, Colombia, Brazil, Spain
Novo Nordisk A/S
40Research sites
7000Patients around the world
This study is for people with
Cardiovascular disease
Established cardiovascular disease
Obesity
Requirements for the patient
From 55 Years
All Gender
Medical requirements
- Male or female.Age above or equal to 55 years at the time of signing informed consent.Body mass index (BMI) greater than or equal to (>=) 25.0 kilograms per meter square (kg/m^2).Established CVD as evidenced by at least one of the following:Prior myocardial infarction.Prior stroke (ischemic or haemorrhagic stroke).Established CVD as evidenced by at least one of the following: Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:Intermittent claudication with an ankle-brachial index (ABI) less than (<) 0.85 at rest.Symptomatic peripheral arterial disease (PAD) defined as at least one of the following: Intermittent claudication with a >= 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computed tomography (CT) angiography or Doppler ultrasound.Established CVD as evidenced by at least one of the following: Symptomatic peripheral arterial disease (PAD) defined as at least one of the following: Prior revascularization procedure of a lower extremity peripheral artery.Established CVD as evidenced by at least one of the following: Symptomatic peripheral arterial disease (PAD) defined as at least one of the following: Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis).For participants with T2D at screening the following inclusion criteria also apply:Diagnosed with type 2 diabetes mellitus (T2D) >= 180 days before screening.For participants with T2D at screening the following inclusion criteria also apply: HbA1c 6.5%-10% (48-86 millimoles per mole [mmol/mol]) (both inclusive), as measured by central laboratory at screening.For participants with T2D at screening the following inclusion criteria also apply: Treatment with either:Lifestyle intervention alone.For participants with T2D at screening the following inclusion criteria also apply: Treatment with either: 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), dipeptidyl peptidase 4 (DPP4)-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label.For participants with T2D at screening the following inclusion criteria also apply: Treatment with either: Basal insulin alone or in combination with up to two marketed OADs, all according to local label.
- Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening.Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or a medication with GLP-1 activity within 90 days before screening.End stage renal disease defined as estimated glomerular filtration rate (eGFR) < 15 millileters per minutes per 1.73^2 (mL/min/1.73 m^2), as measured by the central laboratory at screening.Chronic or intermittent haemodialysis or peritoneal dialysis.
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
Instituto Médico Damic S.R.L.
Recruiting
Instituto de Investigaciones Clínicas San Nicolás
Recruiting
Centro Medico de Nutrición y Diabetes (CENUDIAB)
Recruiting
Consultorio Integral de Atención al Diabético CIAD Morón
Recruiting
Sanatorio Norte SRL - Santiago del Estero
Recruiting
Mautalen - Salud e Investigación - CABA
Recruiting
Hospital Italiano de La Plata
Recruiting
Instituto Medico Catamarca "IMEC"
Recruiting
StudyREDEFINE 3
SponsorNovo Nordisk A/S
Study typeInterventional
Conditions
Established cardiovascular diseaseObesity
Requirements
From 55 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05669755
