A Prospective, multicenter, randomized, non-inferior study to evaluate the effect of Remogliflozin 100 mg vs Dapagliflozin 10 mg in addition to standard of care, in patients of Type 2 Diabetes Mellitus (T2DM) with Chronic Kidney Disease (REMO- CKD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- • Change in renal parameters (eGFR, Sr Creatinine, BUN and uric acid) at 12 weeks and 24 weeks as compared to baseline.
研究概览
简要总结
This is a prospective, multicentre, randomized, open-label, active controlled study to evaluate the effect of Remogliflozin 100 mg vs Dapagliflozin 10 mg in addition to standard of care, in patients of Type 2 Diabetes Mellitus (T2DM) with chronic kidney disease (CKD).
The study would be initiated at each site after review and approval from ethics committee (IRB/IEC). The patients of T2DM with CKD would be screened and written informed consent would be obtained before undertaking any study related procedures. On day of screening (visit 1, Day -7 to 0), basic demographic & clinical characteristics, including age, gender, duration of T2DM, CKD, NYHA and background treatment would be acquired. The physical examination, blood and other laboratory investigations as per Schedule of assessments would be done.The patients would be followed up for next visit for randomization (visit 2, Day 1). On day of randomization (visit 2, Day 1), full eligibility as per the selection criteria would be ascertained and the eligible patients would be randomized to either of treatment groups (Remogliflozin 100 mg or Dapagliflozin 10 mg) as per randomization plan. At the baseline/randomization visit, further detailed medical history along with changes in medications from screening will be obtained. Within the appropriate range of the therapeutic goal, the participant’s background treatment will be, in principle and if possible, unchanged during the trial interval for at least 6 months for CKD (Chronic Kidney Disease) & anti-diabetic medication. Post-randomization follow-up visits are scheduled at 12 weeks (visit 3) and 24 weeks (visit 4).
The Body Mass Index (BMI), Body weight (BW), waist circumference, vitals & physical examination and details of concomitant medications would be recorded at screening, baseline (visit 2), visit 3 and visit 4. Laboratory assessment of Hemogram, Renal function parameters namely eGFR, UACR, Sr Creatinine, Sr BUN, Sr Uric acid, FPG, PPG, HbA1c would be performed at screening, visit 3 and visit 4.
The safety would be assessed by continuous monitoring of treatment emergent adverse events (including AEs of special interest such as hypoglycemic events, urinary tract infection, genital fungal infection, and excess osmotic diuresis signs), safety laboratory values and vital signs.
Treatment and study duration is of 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
- •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.
- •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.
结局指标
主要结局
• Change in renal parameters (eGFR, Sr Creatinine, BUN and uric acid) at 12 weeks and 24 weeks as compared to baseline.
时间窗: 12 weeks & 24 Weeks
• Change in UACR at 12 weeks and 24 weeks as compared to baseline.
时间窗: 12 weeks & 24 Weeks
次要结局
- Patients achieving HBA1C level less than 7%(Week 24)
- Change in FPG, PPG and HBA1C
- Change in Body Weight(at 24 weeks compared to baseline)
- Incidence of adverse event and SAEs(Tretament emergent Adverse event and TSAEs)