Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Dapagliflozin
Empagliflozin: Tablet Dapagliflozin 10 mg to be given orally once daily for a duration of 6 months.
Tablet Empagliflozin 25 mg to be given orally once daily for a duratio
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older who have been diagnosed with type 2 diabetes mellitus and are on stable background therapy for at least three months will be eligible for inclusion. Participants must have an HbA1c between 7 and 10 percent while on metformin with or without other oral hypoglycemic agents, and there should be a clinical indication to initiate an SGLT2 inhibitor. Eligible participants must have a body mass index of 23 kilograms per square meter or higher and should be willing to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Participants with uncontrolled diabetes defined as HbA1c greater than 10 percent, those who have used SGLT2 inhibitors, insulin, or GLP-1 receptor agonists within 90 days prior to randomization, and individuals with a history of bariatric surgery or planned surgery during the study period will be excluded. Current alcohol consumption equal to or exceeding 140 grams per week in women or 210 grams per week in men, corresponding to 14 or 21 standard drinks per week respectively, will also be an exclusion criterion. Acutely ill patients visiting the outpatient department, those receiving drugs known to cause hepatic steatosis such as amiodarone, valproate, tamoxifen, methotrexate, or steroids, and patients with estimated glomerular filtration rate below 45 milliliters per minute per 1.73 square meters will be excluded. Individuals with contraindications to SGLT2 inhibitor use, including history of recurrent urinary tract or genital infections, current or previous gangrene, known allergy to the molecule, or a history of diabetic ketoacidosis, will not be enrolled. Pregnant or breastfeeding women will also be excluded from participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in HbA1c (%) 2.Change in weight (kg)Timepoint: At Baseline and at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in HbA1c (%) and Weight (kg) from baseline at 3 months 2. Change in FBG (mg/dL) from baseline at 3 and 6 months 3. Change in ALT, AST, GGT, lipid profile from baseline at 6 months 4. Changes in LSM and CAP via transient elastography scan from baseline at 6 months 5. Change in SBP and DBP (mmHg) from baseline at 1, 3 and 6 months 6. Change in serum creatinine (mg/dL), eGFR and UACR (mg/g) from baseline at 3 and 6 months 7. Incidence of adverse events, including serious adverse events (SAEs) during the 6-month treatment period in both groups, categorized by type, frequency, and severity. 8. Incidence of Drug-related Discontinuation Timepoint: THREE AND SIX MONTH | — |
Countries
India
Contacts
Public ContactBhavya
All India Institute of Medical Sciences, Bhopal
Outcome results
None listed