A comparative study to assess the effect of Empagliflozin versus Dapagliflozin on circulating markers of calcium-phosphate metabolism in uncontrolled Type2 diabetic patients on Metformin.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Effect of Empagliflozin versus Dapagliflozin on circulating markers of calcium-phosphate metabolism
研究概览
简要总结
India is the emerging capital of Non-Communicable diseases (NCDs). Among NCDs the major share is contributed by Diabetes Mellitus (DM). American Diabetic Association(ADA) 2020 advises on starting SGLT2 inhibitors or DPP4 inhibitors as second line Oral Hypoglycemic Agent. SGLT2 inhibitors like Empagliflozin, Dapagliflozin mainly acts on proximal tubule by inhibiting sodium glucose cotransporter-2 which causes reabsorption of glucose via active cotransport with sodium in PCT. Although these group of drugs have many other therapeutic advantages other than control of blood sugar, several previous studies depict that it also exerts adverse effects on bone health . This necessitates further evaluation, especially comparing the effect of individual SGLT2 inhibitors on bone health. The main aim of the study is to compare the effect of Empagliflozin versus Dapagliflozin on circulating markers of calcium-phosphate metabolism, blood glucose and ADR profile in type2 diabetic patient. Study design: Open labelled Randomized Controlled Trial. The study will be conducted in department of Pharmacology in collaboration with department of General medicine of AIIMS-PATNA. We will include the patients of type 2 DM uncontrolled by Metformin alone. Study will be conducted on type2 diabetes patient who are previously taken Metformin (1000mg/day). Group A will be prescribed Tab. Empagliflozin (25mg) and Group B Tab. Dapagliflozin (10mg) as 2nd line OHA and each of the group will be followed for months and data will be collected for analysis. Sample Size: 64. Each group will have 32 patients. Laboratory findings:Fasting and 2hour Post prandial blood sugar, HbA1c value, Serum phosphate, Serum calcium, Serum PTH, 1,25dihydroxyvitaminD, KFT (S. Creatinine, S. urea, S. Uric acid), LFT (ALT, AST),Lipid Profile (S. Cholesterol, TG, HDL, LDL, VLDL) will be taken on 0 month and 3 month but on 1 month and 2 month , FBS , PPBS will be taken.
After the collection of data, the data will be statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
入选标准
- •1.Previously diagnosed type 2 Diabetes Mellitus patient already on Metformin (1000mg/day) ≥3 month with FBS ≥130 mg/dl or PPBS ≥180mg/dl or HbA1C ≥7%
- •Age: ≥18years and ≤55 years
- •Gender: Both.
排除标准
- •1.Patient already on diabetic treatment on drugs other than Metformin.
- •2.Patient with Renal disease (S.
- •Creatinine ≥1.2mg/dl) Liver disease (ALT/AST >50IU) 3.Pregnant and lactating women 4.Patients unwilling/unable to give consent 5.Patient on drugs which may cause hyperglycaemia like (Steroids, Beta2 agonist, Thiazides, Antipsychotics) .
- •6.Patient on drugs causing hypoglycaemia (Beta blocker, Fluoroquinolones, Pentamidine).
- •Patient on drugs causing derangement of vitamin D, PTH level (Phenytoin, phenobarbital, warfarin, Cyclophosphamide, Tamoxifen, Rifampicin, Antiviral drugs).
- •Patient on vitamin D medication and calcium medication.
- •Patient on drugs which derange calcium metabolism (Thiazides, Loop diuretics).
- •Patient with vitamin D level less than 20 ng/ml.
结局指标
主要结局
Effect of Empagliflozin versus Dapagliflozin on circulating markers of calcium-phosphate metabolism
时间窗: 0 month, 3 month
次要结局
- i) Efficacy of Empagliflozin versus Dapagliflozin on blood glucose parameters.(ii) Adverse drug reaction profile (ADR Profile) in patients receiving Empagliflozin versus Dapagliflozin.)