Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients

NCT ID: NCT06068686

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-12-01

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vildagliptin

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.

Group Type: EXPERIMENTAL

Vildagliptin 50 MG

Intervention Type: DRUG

vildagliptin plus their metformin.

Glimepiride

Group II (N=35) are patients who the endocrinologist prescribed them Glimepiride 3mg / tab plus Metformin 500mg /tab once daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Glimepiride 3 Mg Oral Tablet

Intervention Type: DRUG

glimepiride plus their metformin

Interventions

Vildagliptin 50 MG

vildagliptin plus their metformin.

Intervention Type: DRUG

Glimepiride 3 Mg Oral Tablet

glimepiride plus their metformin

Intervention Type: DRUG

Other Intervention Names

Vildagliptin; Amaryl

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Werida

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rehab H Werida, Ass Prof.

Role: STUDY_CHAIR

Damanhour University

Locations

Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

Damanhūr, Elbehairah, Egypt

Countries

Egypt

Other Identifiers

Vilda. vs Glim. in T2D

Identifier Type: -

Identifier Source: org_study_id