None listed
Conditions
Brief summary
To assess the effect of Dapagliflozin 10 mg on proteinuria in patients of type 2 diabetes mellitus. Although extensively studied internationally, to the best of our knowledge no local study in Pakistan has been conducted to see the effect of Dapagliflozin on proteinuria in Pakistani type 2 diabetic patients. Therefore, we aim to study the above. In this study a total sample size would be 516 patients with diabetes mellitus and proteinuria. The sample size is calculated with the help of OpenEpi sample size calculator, with confidence level (1-a) equal to 95%., power of test of 80% and previously calculated at least 30% reduction of albuminuria of 49.7 % with Dapagliflozin and 37.4 % with Placebo ( Heerspink HJ, Johnsson E, Gause-Nilsson I, Cain VA, Sjöström CD. Dapagliflozin reduces albuminuria in patients with diabetes and hypertension receiving renin-angiotensin blockers. Diabetes Obes Metab. 2016 Jun;18(6):590-7. doi: 10.1111/dom.12654. PMID: 26936519; PMCID: PMC4850750.) All the patients, fulfilling the inclusion criteria of this study would be offered Dapagliflozin 10 mg once daily treatment in the intervention arm and placebo in the control arm after permuted block randomization. 24 hour urinary proteins of these patients would be repeated at 12 weeks interval after treatment with either Dapagliflozin or Placebo. Body weight of all the study participants would be measured at baseline and at 12 weeks. Urinary Tract Infections and Genital Mycotic infections would be seen at baseline and after 12 weeks of in both the intervention and control group.
Interventions
All the patients, fulfilling the inclusion criteria of this study would be offered Dapagliflozin 10 tablet mg once daily per-oral treatment for 12 weeks. This treatment would be given as home self-administered. Compliance would be checked by drug tablet return. 24 hour urinary proteins of these patients would measured at baseline and repeated at 12 weeks interval after treatment with Dapagliflozin.
Sponsors
MTI Lady Reading Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age more than 16 years or older. 2. Gender: Any 3. Patients diagnosed as having type 2 diabetes mellitus (Fasting blood glucose of >126 mg/dl or HbA1C > 6.5 %) who are having proteinuria of more than 150mg / 24 hours already on maximum tolerated dose of Angiotensin Converting Enzyme Inhibitors (ACEi) or Angiotensin receptor Blockers (ARBs).
Exclusion criteria
1. Patients with type 1 diabetes mellitus (SGLT2 inhibitors may precipitate Diabetic Ketoacidosis) 2. Pregnancy (SGLT2 inhibitors not licensed) and 3. Cancer. 4. Patients already on SGLT2 inhibitors 5. Patients on treatments which may impair glucose metabolism, such as immunosuppressant/immunomodulators and systemic or local steroid therapy.
Outcome results
None listed