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Dapagliflozin add-on to metformin therapy in diabetic patients

Dapagliflozin add-on to metformin in type 2 diabetes mellitus those who are inadequatively controlled on a stable dose of metformin- In Shahjahanpur district population

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048622
Enrollment
50
Registered
2022-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Dapagliflozin add-on to metformin in type 2 diabetes mellitus: Dapagliflozin add-on to metformin in type 2 diabetes mellitus those who are inadequatively controlled on a stable dose of

Sponsors

Aditya kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with T2DM inadequately controlled with Metformin 1-2 gm per day 2. Those patients who are unable to tolerate further increase in further dose of Metformin 3. Patients aged 30 to 70 years 4. HbA1C 7.0% to 9.0%

Exclusion criteria

Exclusion criteria: 1. Patient who are on insulin 2. Patient described any other anti diabetic medication after adding Dapagliflozin to Metformin 3. Patients in which dose of metformin has to be altered 4. Patients with renal insufficiency (GFR lress than 30ml/min/1.73m2) 5. Patients who are known case of urinary tract infection , structural abnormalities of urinary tract. 6. Patients with acute complications of diabetes mellitus 7. Patients with hypersensitivity to drug

Design outcomes

Primary

MeasureTime frame
To access the effect of Dapagliflozin on: 1. Glycemic parameters 2. Lipid profile 3. Bmi 4. Blood pressure 5. To study the efficacy of Dapagliflozin Timepoint: Selected patients will be evaluated for Blood Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Urinary albumin creatinine ratio (UACR), Urine R/m, Fasting Blood sugar, 2 hours Post parandial Blood sugar and HbA1c on first visit. These patients will be followed up in OPD every month till 3 months. At the end of 3 months, Blood Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post prandial Blood sugar and HbA1c will be assessed.

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDr Aditya kumar

Varunarjun medical college and rohilkhand hospital

generalmedicine9090@gmail.com9532417395

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026