Comparative effects of dapagliflozin and metformin in obese diabetic patients

Phase 4

• Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

• Registration Number: CTRI/2023/11/059814
• Lead Sponsor: Shobana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

11.History of malignancy

12.Patient with severe UTI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in insulin & growth hormone secretion from baseline to 12 weeksTimepoint: baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in the glucagon & resistin levels from baseline to 12 weeks <br/ ><br>•Change on the anthropometric measurements & biochemical variables LFT lipid profile glycaemic indices <br/ ><br>Timepoint: baseline to 12 weeks <br/ ><br>