NCT06068686

Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients

Effect of Vildagliptin Versus Glimepiride on Copeptin and Fetuin-A in Type 2 Diabetic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Vildagliptin 50 MG	vildagliptin plus their metformin.
DRUG	Glimepiride 3 Mg Oral Tablet	glimepiride plus their metformin

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-11-30
• Completion: 2024-12-01
• First posted: 2023-10-05
• Last updated: 2025-02-04

Locations

1 site across 1 country: Egypt