Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Metformin and Dapagliflozin: metformin tablets 500 mg PO bid plus dapagliflozin tablets 5 mg PO bd
Control Intervention1: Metformin: metformin tablets 500 mg PO bid
Sponsors
N Shobana
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/female aged 18-60 years 2.Newly diagnosed T2DM patients as per the ADA diagnostic criteria 2022 – Hb A1c of 5.7–6.4%, fasting blood glucose of >125 mg/dl for metformin group 3.Uncontrolled T2DM patients who started newly add on therapy with dapagliflozin for metformin +dapagliflozin group 4.Body mass index (BMI) of = 25 kg/m2
Exclusion criteria
Exclusion criteria: 1.Diagnosed T2DM who is already on antidiabetic medication 2.BMI = 24.9 kg/m2 3.Type 1 diabetes mellitus. 4.History of diabetic ketoacidosis or hyperosmolar non-ketotic coma. 5.Hyperthyroidism. 6.Hypothyroidism. 7.Uncontrolled hypertension (blood pressure >150/90 mm Hg). 8.Recent 3 kg weight loss or gain in preceding month. 9.Any history of any serious hypersensitivity reaction to dapagliflozin or metformin 10.On any other SGLT-2 inhibitor 11.History of malignancy 12.Patient with severe UTI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in insulin & growth hormone secretion from baseline to 12 weeksTimepoint: baseline to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the glucagon & resistin levels from baseline to 12 weeks •Change on the anthropometric measurements & biochemical variables LFT lipid profile glycaemic indices Timepoint: baseline to 12 weeks | — |
Countries
India
Contacts
Public ContactDr Satyajit Mohapatra
SRM medical college hospital and research centre
Outcome results
None listed