Effect of Sotagliflozin on CV and renal events in T2DM patients
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, parallel-group, multicentre study to demonstrate the effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function
IRAS ID
234208
Contact name
Cristina Di Ramio
Contact email
Sponsor organisation
Covance Clinical and Periapproval Services Limited
Eudract number
2017-002644-32
Duration of Study in the UK
4 years, 1 months, 10 days
Research summary
The prevalence of Type 2 diabetes (T2D) is increasing worldwide and is associated with cardiovascular risk factors such as abnormal amounts of lipids in the blood, high blood pressure, and obesity. Patients with T2D have double the risk of dying due to cardiovascular complications compared to patients without diabetes. Approximately 50% of patients with T2D also have chronic Kidney disease (CKD).\n\nSotagliflozin is a dual inhibitor of both sodium-glucose linked transporter-2 (SGLT2) and sodium-glucose linked transporter-1 (SGLT1). Sotagliflozin works in the kidney to allow more sugar to be lost in the urine, and also in the intestine to prevent absorption of sugars. In this way, it is thought to help in lowering blood sugar in diabetes. Recent data from other studies indicates that SGLT2 inhibitors may address the unmet need of treatment for prevention of cardiovascular death, heart failure, and worsening of renal impairment in patients with T2D. The dual combination of an SGLT1 and SGLT2 may mean that Sotagliflozin has unique effects on cardiovascular and renal events.\n\nThis study is designed to assess the effect of Sotagliflozin on cardiovascular and renal events in patients with T2D that are already at high cardiovascular risk and have moderate renal impairment. Around 10,500 patients will be enrolled worldwide, with 105 planned in the UK, and will be randomised to either Sotagliflozin or placebo.\n\nThe study is planned to take place in 9 NHS centres in the UK.
REC name
Wales REC 3
REC reference
17/WA/0347
Date of REC Opinion
20 Dec 2017
REC opinion
Further Information Favourable Opinion