Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Control Intervention1: SGLT2 INHIBITORS: Subjects will receive SGLT2i in addition to standard antidiabetic medications. The allowed SGLT2 inhibitors will be
Canagliflozin 100-300mg/day OR Dapaglifloz
Sponsors
Dr Ankita Sharma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged between 30-60 years of either gender 2. Type II DM with a duration of disease >= 3 years. 3. HbA1c level 7.0-9.5% 4. Patients who are SGLT2i naïve patients. 5. Type II DM patients on a stable 2 or 3 drug combinations for the past 3 months. The allowed combination will be Metformin + Sulphonylurea +/- gliptins in the following dosages; Metformin 1000-2500mg/day Glipizide 5-40mg/day Glimepride 1-8 mg/day Gliclazide 30- 120mg/day Sitagliptin 100mg/day Linagliptin 5mg/day Vildagliptin 50-100mg/day Teneligliptin 20-40mg/day 6. Subjects who agree to comply with the study procedures
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to the study drug. 2. Patients used glucagon-like peptide-1 agonists, or insulin in the past 12 weeks. 3. Patients with type 1 diabetes. 4. Subjects with history of liver disease (alanine aminotransferase, alkaline aminotransferase or alkaline phosphatase levels >3 times the upper limit of normal) or kidney disease (serum creatinine >1.1mg/dl) 5. History of chronic smoking or alcohol addiction. 6. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in oxidative stress markers (MDA, NO and glutathione levels)Timepoint: 0 Week,8 Week, 12 Week | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c, FBS and PPBS levelsTimepoint: 0 Week, 12 Week;Change in total cholesterol, triglyceride levels, high-density lipoprotein concentration (HDL-c) and low-density lipoprotein concentration (LDL-c)Timepoint: 0 Week, 12 Week;Correlation of the concentration of iron, TIBC, and ferritin with oxidative stress markers.Timepoint: 0 Week, 12 Week;Incidence of adverse effects in the study populationTimepoint: 0 Week, 4 Week. 8 Week. 12 Week | — |
Countries
India
Contacts
Public ContactDr D Aruna
Nizams institute of medical sciences
Outcome results
None listed