Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2021-08-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Getz Pharma
• Treatments: Empagliflozin; Vildagliptin

Criteria

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