Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Remogliflozin: Patients will receive tablet Remogliflozin 100mg twice daily with tablet Metformin 1000-3000mg daily dosage.
Control Intervention1: Vildagliptin: Will receive tablet Vild
Sponsors
Maulana azad medical college
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1.Change in lipid profile. 2.Change in weight. 3.Frequency of hypoglycemic episodes. 4.Safety profile of both groups.Timepoint: Change in from baseline to 12 weeks | — |
Countries
India
Contacts
Public ContactDr Bhupinder singh
Maulana Azad Medical College
Outcome results
None listed