Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus
- Registration Number
- NCT05359432
- Lead Sponsor
- Getz Pharma
- Brief Summary
The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus
open labelled, multi-centric, parallel, randomized control trial
In Type 2 Diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus vildagliptin (50 mg once or twice daily) assessed for Efficacy \& safety parameters to be measured at both the baseline and 24-week visits.
- Detailed Description
Background:
Diabetes is a rampant disease that keeps on getting more and more people affected each year. Over 200 million people have been affected worldwide due to this disorder, and many have contracted various cardiovascular complications due to uncontrolled diabetes. Though an easily manageable disease, if left untreated, diabetes can be fatal. Therefore, it is necessary to have drugs available which control diabetes and also limit the progression of complications that could arise due to it.
Objective:
The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus
Methods:
open labelled, multi-centric, parallel, randomized control trial to be conducted at the Department of Diabetes \& Endocrinology of two tertiary care hospitals in Karachi, Pakistan.
The Participants will undergo screening and then were randomized into two groups. The first group received empagliflozin (10 mg once or twice daily), and the second group received vildagliptin (50 mg once or twice daily. HbA1c, High-density lipoprotein (HDL) levels., Systolic blood pressure, fasting blood glucose, and body weight will be measured at both the baseline and 24-week visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Female and Male Patients of age 30-65 years with confirmed diagnosis of "type 2 diabetes mellitus".
Uncontrolled type 2 diabetes mellitus (> 7% HbA1c patients on monotherapy of metformin for the past three months on a fixed dose of 1500 mg /day along with lifestyle modifications were included in this study.
BMI ranges from 18-45 kg/m2 were considered fit for this study. eGFR ≥ 60 ml/min/1.73 m2
Pregnant female or female patients planning to conceive during the study period were excluded from this study.
"Type 1 diabetes" or "secondary diabetes" resulting from specific causes Patients with advanced diabetic complications. Patients with any other terminal disease(s) requiring long-term medications. Patients involved in other trials on therapy with SGLT-2i or DPP4-I 3 months before study enrollment Patients on insulin or any other oral hypoglycemic drugs except metformin. Serum creatinine levels ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin Empagliflozin - Vildagliptin Vildagliptin -
- Primary Outcome Measures
Name Time Method High-density lipoprotein (HDL) levels 24 weeks Systolic blood pressure 24 weeks Fasting blood sugars 24 weeks Bodyweight 24 weeks Serum creatinine 24 weeks Serum glutamic-pyruvic transaminase (SGPT) 24 weeks Low-density lipoprotein cholesterol 24 weeks Total cholesterols 24 weeks Serum triglycerides 24 weeks Glycosylated hemoglobin A1c (HbA1c) 24 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Diabetes and Endocrinology at Sindh Government Hospital New Karachi & Dr. Riasat Medical Center Allah Wala Town, Karachi, Pakistan
🇵🇰Karachi, Sindh, Pakistan