Sotagliflozin in Patients with T2DM post worsening Heart Failure
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in HemodynamIcally Stable Patients with Type 2 Diabetes Post Worsening Heart Failure
IRAS ID
242874
Contact name
Azfar Zaman
Contact email
Sponsor organisation
Sanofi-aventis Recherche & Développement
Eudract number
2017-003510-16
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Heart failure is a common comorbidity and complication of Type 2 Diabetes. Patients with Heart Failure have particularly poor outcomes and 5-year survival rates of <25%. The condition known as post-worsening heart failure represents a specific unmet medical need in patients with Type 2 Diabetes, since the rates of hospitalization for Heart Failure in patients with diabetes are substantially higher compared to those for Heart Failure patients without diabetes
Sotagliflozin 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 point to the beneficial effects of SGLT2 inhibitors in reducing cardiovascular death and Heart Failure in patients with Type 2Diabetes.
This study is designed to demonstrate whether sotagliflozin reduces the cardiovascular deaths and hospitalization for heart failure as compared to placebo in diabetic patients after admission for Worsening Heart Failure. Around 4,000 patients will be enrolled worldwide, with 25 planned in the UK, and will be randomised to either Sotagliflozin or placebo.
The population eligible for the study are, adult patients under the age of 85 years with type 2 diabetes, who were recent admitted or received urgent treatment for worsening heart failure.
The study will be funded by Sanofi and is planned to take place in 5 NHS centres in the UK, part of a total of approximately 800 sites world-wide. Patients will participate for between 3 and 32 months, depending when they join the study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0194
Date of REC Opinion
10 Aug 2018
REC opinion
Further Information Favourable Opinion