Investigating tirzepatide versus semaglutide in Type 2 Diabetes
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients with Type 2 Diabetes (SURPASS-2)
IRAS ID
265253
Contact name
Adie Viljoen
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2018-004422-29
Duration of Study in the UK
1 years, 8 months, 3 days
Research summary
The goal of this study is to learn more about the drug tirzepatide in the treatment of type 2 diabetes mellitus (T2DM).
Patients with T2DM have above normal levels of glucose (sugar) in their blood. T2DM is associated with other co-morbidities including increased weight and obesity. To help prevent diabetes related complications, treatments are used to control the high levels of glucose in the blood.
Some treatments target a group of hormones in the body called “incretins”. Incretin hormones are released when food is eaten and help reduce blood glucose levels. In T2DM patients, the effect of incretin hormones is reduced leading to increased blood glucose levels. Therefore, some T2DM therapies work by mimicking the function of one or more of these hormones in the body. The incretin hormone GLP-1 is most commonly targeted.
As not all T2DM patients benefit from current T2DM treatments, there is a need for improved treatments. It has been shown that the novel drug “tirzepatide” differs to other treatments by mimicking two incretin hormones GLP-1 and GIP. It is believed that this drug will offer improved glucose control and weight loss with a low risk of low blood sugar.This is a late phase study investigating if tirzepatide is as good as or better than semaglutide (GLP-1 receptor agonist) at treating T2DM. Patients must be 18 years or over, have been diagnosed with T2DM that is currently uncontrolled by metformin alone (a standard treatment for T2DM), and must be able and willing to self-inject the study drugs (once weekly) and perform blood glucose finger-stick monitoring. Study participants will receive either tirzepatide or semaglutide as well as metformin. Participation in the study will last about 47 weeks. About 1872 participants from around the world will take part in this study including 50 patients from the UK.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0200
Date of REC Opinion
26 Jul 2019
REC opinion
Further Information Favourable Opinion