Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus

Getz Pharma120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Type 2 Diabetes

Interventions

EmpagliflozinDRUG

Receiving allocated drug dosage as per clinical needs

VildagliptinDRUG

Receiving allocated drug dosage as per clinical needs

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: 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

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

Outcomes

Primary Outcomes

Glycosylated hemoglobin A1c (HbA1c)

Time frame: 24 weeks

High-density lipoprotein (HDL) levels

Time frame: 24 weeks

Systolic blood pressure

Time frame: 24 weeks

Fasting blood sugars

Time frame: 24 weeks

Bodyweight

Time frame: 24 weeks

Serum creatinine

Time frame: 24 weeks

Serum glutamic-pyruvic transaminase (SGPT)

Time frame: 24 weeks

Low-density lipoprotein cholesterol

Time frame: 24 weeks

Total cholesterols

Time frame: 24 weeks

Serum triglycerides

Time frame: 24 weeks

Data from ClinicalTrials.gov

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