A Phase 2 Double-blind Randomised Controlled Trial Studying the Effect of Sotagliflozin Versus Placebo in Individuals With Heart Failure and Type 1 Diabetes.

Plain English Summary

Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes is a Phase 2 clinical trial sponsored by University of Dundee studying Type 1 Diabetes, Heart Failure. This trial tests if a drug called sotagliflozin can improve the quality of life for people with type 1 diabetes who also have heart failure symptoms. It is for adults aged 18 to 84 with type 1 diabetes and signs of heart failure. Participants will take either sotagliflozin or a placebo (dummy pill) daily for 4 months, with the study lasting about 26 months. Alternatives for managing heart failure in type 1 diabetes may include lifestyle changes, other heart medications, and blood sugar control. The trial aims to enroll 320 participants.

Official 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 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 84 years old and have type 1 diabetes. You must have symptoms or be at high risk for heart failure, and be willing to use a continuous glucose monitor. You cannot join if you've had recent heart surgery, have severe kidney or liver problems, are pregnant or breastfeeding, or have certain other serious medical conditions. This trial is studying Type 1 Diabetes, Heart Failure, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if sotagliflozin improves how patients feel and function in their daily lives, measured by a score that reflects their heart failure symptoms and quality of life. The specific primary outcome measures are: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (From baseline to week 16). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a gap in understanding how sotagliflozin might benefit patients with type 1 diabetes and heart failure, a population not included in previous studies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Type 1 Diabetes, Heart Failure, where improved treatment options are needed.

Investor Insight

This trial explores a new use for sotagliflozin, a drug class (SGLT inhibitors) with established benefits in heart failure for type 2 diabetes, suggesting potential for a significant market if success Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of sotagliflozin and if this trial is right for you. Participation involves taking a daily pill for 4 months and attending regular study visits for monitoring. You will need to monitor your blood sugar and ketone levels and share this data with the study team. This trial is currently recruiting participants. The trial is being conducted at 17 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 320 participants

Interventions

• DRUG: Sotagliflozin — Sodium-glucose Co-transporter inhibitor
• DRUG: Placebo — Matched placebo

Primary Outcomes

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (From baseline to week 16)

Secondary Outcomes

• Change in KCCQ clinical summary score (From baseline to week 4)
• Change in KCCQ overall summary score (From baseline to weeks 4 and 16)
• Proportion of participants with a ≥5, ≥10 and ≥15 point increase in KCCQ clinical and overall summary scores (From baseline to week 16)
• Change in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) (From baseline to week 16)
• Change in EQ-5D-5L questionnaire score (From baseline to week 16)

Full Eligibility Criteria

Inclusion Criteria:

1. Age 18 years to \<85 years.
2. Type 1 diabetes.
3. Insulin dose ≥0.5 units/kg body weight at screening or BMI ≥25kg/m2 at screening
4. Using continuous glucose monitor at screening or willing to use one for the duration of the trial.
5. 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.
6. New York Heart Association Class II-IV at screening.
7. Kansas City Cardiomyopathy clinical summary score \<85 at screening.

Exclusion Criteria:

1. 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.
2. End-stage heart failure requiring left ventricular assist devices, intra-aortic balloon pump, or any type of mechanical support at the time of randomisation.
3. Documented primary severe valvular heart disease, amyloidosis or hypertrophic cardiomyopathy as principal cause of heart failure as judged by the local investigator.
4. Respiratory disease thought to be the primary cause of dyspnoea as assessed by the local investigator.
5. Chronic kidney disease with estimated glomerular filtration rate \<25ml/min/1.73m2 at screening.
6. Moderate or severe hepatic impairment (e.g. Child-Pugh B and C) at screening as judged by the local investigator.
7. Use of sotagliflozin or any SGLT2 inhibitor within 1 month of screening or between screening and randomisation.
8. Previous hypersensitivity/intolerance to SGLT2 inhibitors.
9. Presence of malignancy with expected life expectancy \<1 year at screening.
10. Severe hypoglycaemia (hospitalisation for hypoglycaemia or episode requiring external assistance to treat) within 1 month prior to screening or between screening and randomisation.
11. One episode of diabetic ketoacidosis or nonketotic hyperosmolar state within 1 month of screening or between screening and randomisation, or ≥2 diabetic ketoacidosis or nonketotic hyperosmolar state events within 6 months of screening.
12. Pregnant or lactating women.
13. Women of childbearing age or male partners of women of childbearing age and not practicing an acceptable method of birth control, see section 8.11
14. On a ketogenic diet.
15. Unwilling/unable to share glucose and ketone monitoring data.
16. Use of any investigational drugs within five times of the elimination half-life after the last dose or within 30 days, whichever is longer. Current enrolment in non-interventional, observational studies will be allowed.

Trial Locations

• Aberdeen Royal Infirmary, Aberdeen, United Kingdom
• Addenbrookes Hospital, Cambridge, United Kingdom
• Ninewells Hospital, Dundee, United Kingdom
• Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
• Glasgow Royal Infirmary, Glasgow Clinical Research Facility, Glasgow, United Kingdom
• Leicester General Hospital, Leicester, United Kingdom
• Aintree University Hospital, Liverpool, United Kingdom
• Prince Philip Hospital, Llanelli, United Kingdom
• Guy's Hospital, London, United Kingdom
• St George's University Hospitals NHS Foundation Trust, London, United Kingdom
• ...and 7 more locations

Frequently Asked Questions

Related Conditions

• Type 1 Diabetes
• Heart Failure
• Cardiomyopathy
• Diabetic Ketoacidosis
• Hypoglycemia
• Kidney Disease
• Liver Disease
• Atrial Fibrillation
• Left Ventricular Dysfunction
• Metabolic Syndrome

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