A Phase 2 Double-blind Randomised Controlled Trial Studying the Effect of Sotagliflozin Versus Placebo in Individuals With Heart Failure and Type 1 Diabetes.
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 it is not known if these benefits also apply to this population. This trial aims to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the United Kingdom (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.
• Age 18 years to \<85 years.
• Type 1 diabetes.
• Insulin dose ≥0.5 units/kg body weight at screening or BMI ≥25kg/m2 at screening
• Using continuous glucose monitor at screening or willing to use one for the duration of the trial.
• Diagnosis of heart failure (HF) or high-risk for HF, defined as any of the following:
• NT-proBNP ≥250ng/L for those in atrial fibrillation/flutter, ≥125 ng/L for those in all other rhythms or
• Previous HF hospitalisation where HF was documented as the primary cause of hospitalisation and there was a requirement for loop diuretics or Impaired left ventricular (LV) function (i.e. LVEF \<50% by any imaging modality) at any time or Preserved LV systolic function (LVEF ≥50%) with left atrial enlargement (2-dimensional measurement of left atrial width ≥3.8cm or left atrial length ≥5.0 cm or left atrial area ≥20cm2 or left atrial volume index \>29 ml/m2) within the last 24 months.
• or Preserved LV systolic function (LVEF ≥50%) with left ventricular hypertrophy (2-dimensional measurement of end-diastolic interventricular septal diameter ≥1.2cm or end-diastolic left ventricular posterior wall diameter ≥1.2cm) within the last 24 months.
• or Preserved LV systolic function (LVEF ≥50%) with diastolic dysfunction (septal e' \<7cm/sec or lateral e' \<10cm/sec or average E/e' ≥15) within the last 24 months.
• New York Heart Association Class II-IV at screening.
• Kansas City Cardiomyopathy clinical summary score \<85 at screening.