Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes Mellitus, Empagliflozin, Vildagliptin, Efficacy, Safety
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.
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.
Interventions
DRUGEmpagliflozin
Receiving allocated drug dosage as per clinical needs
DRUGVildagliptin
Receiving allocated drug dosage as per clinical needs
Sponsors
Getz Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
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
Design outcomes
Primary
| Measure | 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 |
Countries
Pakistan
Outcome results
None listed