Status:
COMPLETED
Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus
Lead Sponsor:
Getz Pharma
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-65 years
Phase:
PHASE4
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, randomi...
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 contr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05359432
Start Date
July 1 2020
End Date
August 18 2021
Last Update
May 3 2022
Active Locations (1)
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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