Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Vildagliptin 50 MG
* Drug: Glimepiride 3 Mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 70 enrolled patients will be divided into two groups (35 each); 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br>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. | Drug: Vildagliptin 50 MG<br>* vildagliptin plus their metformin.<br>* Other names: Vildagliptin;|
| Active Comparator: Glimepiride<br>Group II (N=35) are patients who the endocrinologist prescribed them Glimepiride 3mg / tab plus Metformin 500mg /tab once daily for 12 weeks. | Drug: Glimepiride 3 Mg Oral Tablet<br>* glimepiride plus their metformin<br>* Other names: Amaryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Copeptin Concentration (pg/ml) | Copeptin serum Level | 3 month | 
| NT-proBNP Concentration (pg/ml) | NT-proBNP serum Level | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose (mg/dl) | Fasting Blood Glucose level | 3 month |