Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus

Sponsor

Getz Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT05359432

Collaborator

(none)

120

Enrollment

Location

Arms

13.6

Actual Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Empagliflozin Drug: Vildagliptin	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Aug 10, 2021

Actual Study Completion Date :

Aug 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Empagliflozin	Drug: Empagliflozin Receiving allocated drug dosage as per clinical needs
Experimental: Vildagliptin	Drug: Vildagliptin Receiving allocated drug dosage as per clinical needs

Arm

Intervention/Treatment

Experimental: Empagliflozin

Drug: Empagliflozin

Receiving allocated drug dosage as per clinical needs

Experimental: Vildagliptin

Drug: Vildagliptin

Receiving allocated drug dosage as per clinical needs

Outcome Measures

Primary Outcome Measures

Glycosylated hemoglobin A1c (HbA1c) [24 weeks]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Diabetes and Endocrinology at Sindh Government Hospital New Karachi & Dr. Riasat Medical Center Allah Wala Town, Karachi, Pakistan	Karachi	Sindh	Pakistan	75330