Effect of Empagliflozin versus Dapagliflozin on calcium-phosphate metabolism.
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2023/01/049154
- Lead Sponsor
- All India Institute Of Medical Sciences, Patna
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 64
- 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% 2.
- Age: ≥18years and ≤55 years 3.
- Gender: Both.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of Empagliflozin versus Dapagliflozin on circulating markers of calcium-phosphate metabolism 0 month, 3 month
- Secondary Outcome Measures
Name Time Method i) Efficacy of Empagliflozin versus Dapagliflozin on blood glucose parameters. ii) Adverse drug reaction profile (ADR Profile) in patients receiving Empagliflozin versus Dapagliflozin.
Trial Locations
- Locations (1)
AIIMS PATNA
🇮🇳Patna, BIHAR, India
AIIMS PATNA🇮🇳Patna, BIHAR, IndiaDR SHUVASREE PAYRAPrincipal investigator8942026986shuvasreepayra2019@gmail.com