Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients

• Sponsor: Damanhour University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06068686
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Vildagliptin 50 MG; Drug: Glimepiride 3 Mg Oral Tablet	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Double (Participant, Investigator)
• Masking Description: Double Blind
• Primary Purpose: Treatment
• Official Title: Effect of Vildagliptin Versus Glimepiride on Copeptin and Fetuin-A in Type 2 Diabetic Patients
• Actual Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 30, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Copeptin Concentration (pg/ml) [3 month]

   Copeptin serum Level

2. NT-proBNP Concentration (pg/ml) [3 Months]

   NT-proBNP serum Level

Secondary Outcome Measures

1. Fasting blood glucose (mg/dl) [3 month]

   Fasting Blood Glucose level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.	Damanhūr	Elbehairah	Egypt	31527

Sponsors and Collaborators

• Damanhour University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rehab Werida, Associate Professor, Damanhour University
• ClinicalTrials.gov Identifier: NCT06068686
• Other Study ID Numbers: Vilda. vs Glim. in T2D
• First Posted: Oct 5, 2023
• Last Update Posted: Oct 5, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glimepiride; Vildagliptin

Study Results

No Results Posted as of Oct 5, 2023