Type 2 Diabetes
Conditions
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.
Interventions
vildagliptin plus their metformin.
DRUGGlimepiride 3 Mg Oral Tablet
glimepiride plus their metformin
Sponsors
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Copeptin Concentration (pg/ml) | 3 month | Copeptin serum Level |
| NT-proBNP Concentration (pg/ml) | 3 Months | NT-proBNP serum Level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose (mg/dl) | 3 month | Fasting Blood Glucose level |
Countries
Egypt
Outcome results
None listed