Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-84
SponsorUniversity of Dundee
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Cardiac surgery (coronary artery bypass graft or valve replacement), type 1 myocardial infarction, implantation of cardiac device (including biventricular pacemaker) or cardiac mechanical support implantation within 1 month of screening, or between screening and randomisation, or planned during the trial.
End-stage heart failure requiring left ventricular assist devices, intra-aortic balloon pump, or any type of mechanical support at the time of randomisation.
Documented primary severe valvular heart disease, amyloidosis or hypertrophic cardiomyopathy as principal cause of heart failure as judged by the local investigator.
Respiratory disease thought to be the primary cause of dyspnoea as assessed by the local investigator.
Trial design
Treatments tested in this trial
- Sotagliflozin
- Placebo
Treatment groups
320 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Dundee
Lead sponsor
Lexicon Pharmaceuticals
Collaborator
Juvenile Diabetes Research Foundation
Collaborator
Source ClinicalTrials.gov