Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients

NCT06068686 | Completed

• 1 other identifier: Vilda. vs Glim. in T2D
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Copeptin Concentration (pg/ml)

  Copeptin serum Level

  3 month

• NT-proBNP Concentration (pg/ml)

  NT-proBNP serum Level

  3 Months

Secondary Outcomes (1)

• Fasting blood glucose (mg/dl)

  3 month

Study Arms (2)

Vildagliptin

EXPERIMENTAL

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

Glimepiride

ACTIVE COMPARATOR

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

Interventions

Vildagliptin 50 MG DRUG

vildagliptin plus their metformin.

Also known as: Vildagliptin

Vildagliptin

Glimepiride 3 Mg Oral Tablet DRUG

glimepiride plus their metformin

Also known as: Amaryl

Glimepiride

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 70 uncontrolled adult patients with Type II-diabetes mellitus

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

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

Damanhūr, Elbehairah, 31527, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin; glimepiride; Tablets

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Rehab H Werida, Ass Prof.

  Damanhour University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 5, 2023
• Study Start: October 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 1, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)