Evaluation of the effectiveness and safety of daily versus alternate day dapagliflozin therapy among patients with type 2 diabetes mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complicationsHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/12/038868
- Lead Sponsor
- Department of Science Technology Renewable Energy Chandigarh Administration Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male and female patients with T2DM visiting the General Medicine/Endocrinology OPD/Ward who are taking stable dose of metformin more than or equal to 1500 mg per day therapy for a duration 3 months or more.
2.Age 18-59 years
3.Glycosylated hemoglobin (HbA1c) values between 7-9%
- Subjects with type 1 DM
-Patients who have taken metformin treatment for a duration of less than 3 months
-Patients taking add on anti-diabetic drugs over and above metformin
-Patients having allergy to any of the study drugs
-Pregnant and lactating women
-Patients with kidney dysfunction (serum
creatinine level more than 1.5 times more than the upper limit of normal range)
- Patients with hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase levels 3-fold more than the upper limit of normal range)
-Patients having acute infections, recent trauma or surgery for which the treatment is ongoing and patients have not yet recovered
-Patients with history of recent diabetic ketoacidosis
-Patients with history of active cancer or past history of cancer
-Patients with past history of family history of urinary bladder cancer
-Patients presenting with hematuria or symptoms and signs suggestive of bladder cancer
-Patients who are not able or willing to give a written informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c levelTimepoint: at 3 months and 6 months (from baseline)
- Secondary Outcome Measures
Name Time Method 1. Change in FBS level <br/ ><br> 2. Difference in occurrence of adverse drug events among 2 <br/ ><br>Groups <br/ ><br> <br/ ><br>Timepoint: 1. at 3 months and 6 months (from baseline) <br/ ><br>2. at 6 months