Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients

• Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
• All participants agreed to take part in this clinical study and provide informed consent.
• Patients with uncontrolled DM type 2 who are on metformin will be enrolled from endocrinology clinic at Damanhour general hospital.
• Serum samples will be collected for measuring the biomarkers.
• 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.
• All patients will be followed up during 12 week period.
• At the end of the 12 week period, serum samples will be recollected for measuring the biomarkers after treatment.
• Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
• Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 12 weeks.
• 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.

Inclusion criteria

• 70 uncontrolled adult patients with Type II-diabetes mellitus

Exclusion criteria

• Hepatic impairment.
• Active malignancy.
• Planned surgical intervention.
• Any signs of hypersensitivity or contraindication to study drugs developed.
• Addition of any anti-diabetic medications or insulin during follows up.
• Chronic inflammatory disease (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection).
• Pregnancy, lactation or child-bearing potential.
• Cardiac disease.
• Renal impairment.
• History of T1DM, SIAD, or diabetes insipidus.
• Therapy with any diuretic or a medication affecting the RAAS.