Clinical trial NCT06068686: Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients
Official title: Effect of Vildagliptin Versus Glimepiride on Copeptin and Fetuin-A in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Copeptin Concentration (pg/ml)
timeFrame: 3 month
measure: NT-proBNP Concentration (pg/ml)
timeFrame: 3 Months
Secondary outcomes:
measure: Fasting blood glucose (mg/dl)
timeFrame: 3 month
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
state: Elbehairah
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Ass Prof.
role: STUDY_CHAIR
References: