Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Empagliflozin
* Drug: Vildagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empagliflozin<br> | Drug: Empagliflozin<br>* Receiving allocated drug dosage as per clinical needs<br>|
| Experimental: Vildagliptin<br> | Drug: Vildagliptin<br>* Receiving allocated drug dosage as per clinical needs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Empagliflozin, Vildagliptin, Efficacy, Safety