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NCT Number: NCT05359432

Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Diabetes and Endocrinology at Sindh Government Hospital New Karachi & Dr. Riasat Medical Center Allah Wala Town, Karachi, Pakistan

Karachi, Sindh, 75330, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin

Drug

Receiving allocated drug dosage as per clinical needs

Vildagliptin

Drug

Receiving allocated drug dosage as per clinical needs

Primary outcomes

  1. Glycosylated hemoglobin A1c (HbA1c)

    Time frame: 24 weeks

  2. High-density lipoprotein (HDL) levels

    Time frame: 24 weeks

  3. Systolic blood pressure

    Time frame: 24 weeks

  4. Fasting blood sugars

    Time frame: 24 weeks

  5. Bodyweight

    Time frame: 24 weeks

  6. Serum creatinine

    Time frame: 24 weeks

  7. Serum glutamic-pyruvic transaminase (SGPT)

    Time frame: 24 weeks

  8. Low-density lipoprotein cholesterol

    Time frame: 24 weeks

  9. Total cholesterols

    Time frame: 24 weeks

  10. Serum triglycerides

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Getz Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 3, 2022
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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