Tirzepatide vs Dulaglutide on CV events in high risk T2DM patients
Research type
Research Study
Full title
Protocol I8F-MC-GPGN The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)
IRAS ID
276439
Contact name
Melanie Davies
Contact email
Eudract number
2019-002735-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 4 months, 17 days
Research summary
The goal of this study is to determine how Tirzepatide compares to Dulaglutide in preventing cardiovascular (CV) events in participants with type 2 diabetes mellitus (T2DM) and established cardiovascular disease.
Patients with T2DM have above normal levels of glucose (sugar) in their blood. T2DM is associated with comorbidities such as obesity, hypertension, dyslipidemia, and a higher risk of cardiovascular disease such as heart attack or stroke. To help prevent diabetes related complications, in addition to addressing comorbidities as part of standard care, treatments are used to control the high levels of glucose in the blood.
Tirzepatide acts on the pathways of a group of hormones in the body called “incretins”. Incretin hormones are released when food is eaten and help to reduce blood glucose levels. Tirzepatide is a high potential, long-term agonist of the incretin hormones GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like-peptide-1) in the body. Treatment with Tirzepatide has been shown to markedly reduce blood glucose levels, reduce serum triglyceride concentration and result in meaningful weight loss in patients with T2DM, effects potentially beneficial for the prevention of CV complications.
This is a phase 3, event driven study comparing the effect of once weekly Tirzepatide versus Dulaglutide on cardiovascular (CV) outcomes in patients with T2DM and elevated cardiovascular risk. Patients must be at least 40 years old, with a diagnosis of T2DM, and have established CV disease. Study participants will be randomly assigned to receive once weekly Tirzepatide or Dulaglutide. Neither the patient nor the study doctor will know what medication the patient is receiving. The duration of participation in the study depends on how long it takes for 1615 participants to experience a certain cardiovascular event, but is estimated at 4.5 years. There will be approximately 12,500 participants worldwide, including 150 participants from the UK.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
20/ES/0031
Date of REC Opinion
13 Apr 2020
REC opinion
Further Information Favourable Opinion