Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients

January 18, 2024 updated by: Rehab Werida, Damanhour University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Elbehairah
      • Damanhūr, Elbehairah, Egypt, 31527
        • Recruiting
        • Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
        • Principal Investigator:
          • Noha El Bassiouny, Lecturer
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zeyad M beshara, bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Vildagliptin 50 MG
vildagliptin plus their metformin.
Other Names:
  • Vildagliptin
Active Comparator: Glimepiride
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
glimepiride plus their metformin
Other Names:
  • Amaryl

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Study Chair: Rehab H Werida, Ass Prof., Damanhour University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vilda. vs Glim. in T2D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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