CTRI/2023/11/059814
Not Yet Recruiting
Phase 4
Effect of dapagliflozin and metformin compared to metformin monotherapy on metabolic-regulating hormones in diabetic patients with obesity– A Randomized Controlled Trial - NI
Shobana0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Sponsor
- Shobana
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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