Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications
Conditions
Interventions
Intervention1: Remogliflozin Etabonate (RE), 100 mg: one tablet twice daily for 24 weeks
Control Intervention1: Dapagliflozin 10 mg: one tablet once daily for 24 weeks
Sponsors
Prof Dr Hemant Gupta
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adults (more than or equal to 18 years) of either gender diagnosed with Type-2 Diabetes Mellitus more than 6 months back 2) Having uncontrolled glycaemia (HbA1c more than 7.0 percent & Less than 9.0 percent) with no change in anti-diabetic treatment therapy since last 8 weeks 3) On stable therapy (more than 6weeks prior to screening) of metformin monotherapy or dual therapy of metformin plus other OHA 4) Patients who are on following concomitant background medications for CKD management: ACEi and ARB if not medically contraindicated -With comorbid chronic kidney disease diagnosed at least 3 months prior to screening 5) Patients with eGFR more than or equal to 25 ml per min per 1.73m2 to Less than or equal to 60 ml per min per 1.73m2 at time of initiation of treatment 6) Evidence of increased albuminuria 3 months or more and UACR more than or equal to 200 and less than or equal to 5000 mg per g at visit 1 7) Patients requiring treatment with SGLT2i for T2DM management as part of routine clinical practice 8) Patients who understand & willing to comply with study requirements and provide written informed consent for participation
Exclusion criteria
Exclusion criteria: 1) Female patients who are pregnant or breast feeding 2) Patients with known liver or kidney dysfunction (eGFR less than 25 ml per min per 1.73m2) at time of initiation of treatment. 3) Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis 4) Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment. 5) History of organ transplantation 6) Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor 7) New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment 8) MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change in renal parameters (eGFR, Sr Creatinine, BUN and uric acid) at 12 weeks and 24 weeks as compared to baseline. â?¢ Change in UACR at 12 weeks and 24 weeks as compared to baseline. Timepoint: 12 weeks & 24 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Body WeightTimepoint: at 24 weeks compared to baseline;Change in FPG, PPG and HBA1C Timepoint: at 12 weeks and 24 weeks compared to baseline;Incidence of adverse event and SAEs Tretament emergent Adverse event and TSAEsTimepoint: Baseline to week 24;Patients achieving HBA1C level less than 7%Timepoint: Week 24 | — |
Countries
India
Contacts
Public ContactProf Dr Hemant Gupta
Grant Govt. Medical college and Sir JJ. Group of Hospitals
Outcome results
None listed