NCT05359432

Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus

Comparison of Empaglifozin and Vildagliptin in Efficacy and Safety in Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Getz Pharma · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Empagliflozin	Receiving allocated drug dosage as per clinical needs
DRUG	Vildagliptin	Receiving allocated drug dosage as per clinical needs

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-08-10
• Completion: 2021-08-18
• First posted: 2022-05-03
• Last updated: 2022-05-03

Locations

1 site across 1 country: Pakistan