Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068686
• Other study ID #: Vilda. vs Glim. in T2D
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2024
• Source: Damanhour University
• Contact: Rehab H Werida, Ass. Prof.
• Phone: +201005359968
• Email: rehabwrieda[@]pharm.dmu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 1, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Vildagliptin 50 MG
vildagliptin plus their metformin.
• Glimepiride 3 Mg Oral Tablet
glimepiride plus their metformin

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.	Damanhur	Elbehairah

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Copeptin Concentration (pg/ml)	Copeptin serum Level	3 month
Primary	NT-proBNP Concentration (pg/ml)	NT-proBNP serum Level	3 Months
Secondary	Fasting blood glucose (mg/dl)	Fasting Blood Glucose level	3 month