Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT06068686
- Lead Sponsor
- Damanhour University
- Brief Summary
The aim of this study is to evaluate the effect of vildagliptin on copeptin in comparison to glimepiride, and whether copeptin could be used as a marker for the efficacy of vildagliptin in type 2 diabetes mellitus patients, and how copeptin correlates with other diabetic and cardiac markers.
- Detailed Description
1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
2. All participants agreed to take part in this clinical study and provide informed consent.
3. Patients with uncontrolled DM type 2 who are on metformin will be enrolled from endocrinology clinic at Damanhour general hospital.
4. Serum samples will be collected for measuring the biomarkers.
5. All enrolled patients will be divided into two groups; both groups will be patients who are uncontrolled and already on metformin, group I will receive vildagliptin as an add-on therapy while group II will receive glimepiride.
6. All patients will be followed up during 12 week period.
7. At the end of the 12 week period, serum samples will be recollected for measuring the biomarkers after treatment.
8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
9. Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 12 weeks.
10. Results, conclusion, discussion and recommendations will be given. Methodology
* Copeptin and NT-proBNP will be determined by ELISA.
* Lipid profile will be measured.
* Fasting blood glucose and Insulin will be measured and HOMA-IR will be calculated for all subjects.
* Body weight and blood pressure will be measured.
* HbA1C will be measured.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glimepiride Glimepiride 3 Mg Oral Tablet Group II (N=35) are patients who the endocrinologist prescribed them Glimepiride 3mg / tab plus Metformin 500mg /tab once daily for 12 weeks. Vildagliptin Vildagliptin 50 MG Group I (N=35) are patients who the endocrinologist prescribed them Vildagliptin 50mg /tab plus their Metformin 500mg /tab once daily for 12 weeks to control their blood sugar level.
- Primary Outcome Measures
Name Time Method NT-proBNP Concentration (pg/ml) 3 Months NT-proBNP serum Level
Copeptin Concentration (pg/ml) 3 month Copeptin serum Level
- Secondary Outcome Measures
Name Time Method Fasting blood glucose (mg/dl) 3 month Fasting Blood Glucose level
Trial Locations
- Locations (1)
Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
🇪🇬Damanhūr, Elbehairah, Egypt