Sotagliflozin in Patients with Heart Failure Symptoms and Type 1 Diabetes - SOPHIST
Research type
Research Study
Full title
A phase 2 double-blind randomised controlled trial studying the effect of sotagliflozin 200mg once daily versus placebo in individuals with heart failure and type 1 diabetes on quality of life measured using the Kansas City Cardiomyopathy Questionnaire.
IRAS ID
1007807
Contact name
Ify Mordi
Contact email
Sponsor organisation
University of Dundee
ISRCTN Number
ISRCTN79322795
Clinicaltrials.gov Identifier
NCT06435156
Research summary
People with type 1 diabetes sometimes develop heart failure which can cause symptoms like breathlessness, tiredness or ankle swelling, reduced quality of life and lead to being admitted to hospital or suffering potential fatal consequences. This trial is investigating if a tablet called sotagliflozin, can improve quality of life in people with type 1 diabetes and heart failure. In addition, this trial will also assess the safety and tolerability of sotagliflozin in this population.
In previous trials that included people with type 2 diabetes and heart failure sotagliflozin was shown to improve patients’ symptoms of heart failure, quality of life and reduce the chance of people with heart failure being admitted to hospital or dying. However, people with type 1 diabetes and heart failure were not included in these trials meaning that we do not know if these benefits also apply to this population.
In this trial we aim to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the UK. This trial will compare the health and quality of life of participants who take sotagliflozin tablets with participants who take placebo tablets, which is a dummy tablet that looks the same as sotagliflozin. Participants will be randomly allocated to one of two groups (i.e. one taking sotagliflozin and the other the placebo) and both the medical team and participants will not know in which group each participant is until the end of the study. Participants will be in the trial for approximately 6 months and will be given sotagliflozin or placebo tablets to take 1 per day for 4 months. The trial is expected to run for a total of 26 months.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
24/YH/0028
Date of REC Opinion
18 Mar 2024
REC opinion
Further Information Favourable Opinion