Health TrialsbyHealthPanel

Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes

ConditionsType 1 DiabetesHeart Failure
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Sotagliflozin

    Drug

    Sodium-glucose Co-transporter inhibitor

  • Placebo

    Drug

    Matched placebo

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: SotagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score

To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on quality of life (QoL). KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).

Time frame
From baseline to week 16

Secondary outcomes

1

Change in KCCQ clinical summary score

To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).

Time frame
From baseline to week 4
2

Change in KCCQ overall summary score

To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. KCCQ overall summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).

Time frame
From baseline to weeks 4 and 16
3

Proportion of participants with a ≥5, ≥10 and ≥15 point increase in KCCQ clinical and overall summary scores

To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status). KCCQ overall summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).

Time frame
From baseline to week 16
4

Change in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc)

To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. Treatment satisfaction status score (no unit, ranges from 0 to 36, with higher scores reflecting greater treatment satisfaction). Treatment satisfaction change score (no unit, designed to overcome ceiling effects and to detect changes in treatment satisfaction on a scale from -18 to 18 with negative scores reflecting decreased treatment satisfaction, 0 reflecting no change and positive scores reflecting increased treatment satisfaction).

Time frame
From baseline to week 16

Other outcomes

1

Change in New York Heart Association (NYHA) class

To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes

Time frame
From baseline to weeks 16 and 20
2

Change in daily loop diuretic dose

To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes

Time frame
From baseline to week 16
3

Change in systolic and diastolic blood pressure.

To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes

Time frame
From baseline to week 16
4

Number of hospitalizations and deaths (first and total number) due to heart failure

To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes

Time frame
From baseline to weeks 16 and 20

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Dundee

Lead sponsor

Lexicon Pharmaceuticals

Collaborator

Juvenile Diabetes Research Foundation

Collaborator

Source ClinicalTrials.gov
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