Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Remogliflozin Etabonate 100 mg: Twice daily to be taken orally for 24 weeks
Control Intervention1: Empagliflozin 25mg: Once daily to be taken orally for 24 weeks
Sponsors
Sengupta Hospital and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (â�¥ 18 years) of either gender diagnosed with Type-2 Diabetes Mellitus more than 6 months back 2. Having uncontrolled glycaemia (HbA1c >6.5 & 3. With comorbid Chronic heart failure diagnosed at least 3 months prior to screening & in NYHA HF Class I to III during screening) without change in NYHA functional classification prior to randomization 4. Having reported reduced EF (defined as LVEF 5. Having elevated NT-proBNP levels >600 pg/mL (or >1200 pg/mL in patients with AF) analysed at central Appropriate dose of medical therapy (such as ACEi, ARB, �²-blocker, oral diuretics, MRA, ARNI, ivabradine) and/or appropriate device therapy, consistent with prevailing CV guidelines & local practice, stable for at least 3 week prior to Visit 1(screening) and during screening period until Visit 2 (Randomisation) with the exception of diuretics stable for only one week prior to Visit 2 to control symptoms. 6. Patients who understand & willing to comply with study requirements and provide written informed consent for participation
Exclusion criteria
Exclusion criteria: 1. Patients who are being treated or have been treated with SGLT2i in past 12 weeks 2. Patients with evidence of Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA in past 12 weeks prior 3. Heart transplant recipient, or listed for heart transplant implanted left ventricular assist device (LVAD) at screening 4. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy, induced by chemotherapy or peripartum or known pericardial constriction 5. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial in the investigatorââ?¬•s opinion 6. Acute decompensated HF (exacerbation of chronic HF) requiring IV diuretics, IV, inotropes, or i.v. vasodilators, or LVAD within 1 week from discharge to Visit 1 (Screening) and during screening period until Visit 2 (Randomisation) 7. Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 1(Screening) 8. Untreated ventricular arrhythmia with syncope in patients without ICD documented within the 3 months prior to Visit 1 9. Implanted cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) within 3 months prior to Visit 1, or if there is an intent to implant ICD or CRT within 6 months of visit 2 10. Symptomatic bradycardia or second or third degree heart block without a pacemaker after adjusting beta-blocker therapy, if appropriate 11. Systolic blood pressure (SBP) ââ?°Â¥ 180 mmHg at Visit 2. If SBP >150mmHg and 12. Symptomatic hypotension and/or a SBP 13. Type 1 diabetes mellitus 14. History of diabetic ketoacidosis, diabetic coma, or hypoglycemic attack ââ?°Â¤6 months prior to screening 15. Patients with eGFR 16. Patients with severe organ system disorders viz. Hepatic, Renal, Neoplastic, Neurological or Psychiatric disorders. 17. Patients with planned surgery in next 24 weeks or has undergone major operative procedure in past 3 months 18. CHF (NYHA functional classification IV) 19. Patients with pituitary or adrenal dysfunction 20. Patients with malnutrition, starvation, irregular eating pattern, lack of dietary intake, or debilitation or with a gastrointestinal disorder, such as diarrhea or vomiting, or Gastrointestinal surgery that could interfere with trial medication absorption in the investigatorââ?¬•s opinion 21. Patients with low or high body weight (BMI 45 kg/m2) 22. History of hypersensitivity to ingredients of SGLT2 inhibitors 23. Pregnant or suspected pregnancy in females, Lactating females & Patients of child bearing potential not willing to use effective non-hormonal method of contraception 24. Patients with severe infection or trauma at trial screening 25. Considered inappropriate for the study by investigators due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change from baseline in NT-proBNP levelTimepoint: After 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in proportion of patients in NYHA functional classificationTimepoint: From baseline to 12 weeks and 24 weeks;Incidence of treatment emergent adverse events (TEAEs) assessed by any abnormal symptom, clinical signs or laboratory valueTimepoint: 24 weeks;Mean change from baseline in ECHO parameters (LV Size and Volume, LA size and Volume, E/eââ?¬â?¢, LVEF, LV GLS, Grade of Diastolic dysfunction, PA pressure)Timepoint: After 24 weeks of treatment;Mean change from baseline in HbA1c, FPG levels, PPG levels, Body weight, Waist circumferenceTimepoint: Week 12 and 24;Mean change from baseline in Lipid profile, Systolic and diastolic blood pressureTimepoint: Week 12 and 24;Mean change from baseline renal function parameters (eGFR, UPCR, Sr. Creatinine, Sr. BUN, Sr Uric acid)Timepoint: 24 weeks;Mean percentage change from baseline in NT-proBNP levelTimepoint: After 4 and 12 weeks of treatment;Proportion of patients achieving good glycemic control (HbA1cââ?°Â¤7%)Timepoint: After 24 weeks;Proportion of patients with incidence of any major adverse CV events viz. non-fatal MI, non-fatal stroke, hospitalization for HF, CV-related deathTimepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr Shantanu Sengupta
Sengupta Hospital and Research Institute
Outcome results
None listed