Comparison of Remogliflozin with vildagliptin in the treatment of diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2020/02/023120
- Lead Sponsor
- Maulana azad medical college
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients with age between 35 to 70 years of all sexes.
2.Patients with diagnosis of type 2 diabetes mellitus with uncontrolled glycaemia on taking metformin alone.
1.Patients on any other anti-diabetic medications other than metformin.
2. Patients having hepatic dysfunction (aspartate aminotransferase/alanine aminotransferase �2.5 times of upper normal limit [UNL] or bilirubin > 2 times of UNL).
3.Patient with renal dysfunction (with estimated glomerular filtration rate [eGFR] as per MDRD formula < 45 ml/min/1.73 m2.
4.Patients with genitourinary tract infections.
5.Patients with lower limb cellulitis, ulcer and amputations.
6.Patients with osteoporosis and bone fractures.
7.Patients with acute pancreatitis.
8.Patients with comorbid serious illness such as tuberculosis, HIV, malignancy.
9.Patients allergic to the study medications.
10. Pregnant female patients and nursing mothers will also be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Haemoglobin A1c levels from baseline to 12 weeks of treatment.Timepoint: Change in Haemoglobin A1c levels from baseline to 12 weeks of treatment.
- Secondary Outcome Measures
Name Time Method 1.Change in lipid profile. <br/ ><br>2.Change in weight. <br/ ><br>3.Frequency of hypoglycemic episodes. <br/ ><br>4.Safety profile of both groups.Timepoint: Change in from baseline to 12 weeks