Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients | NCT06068686

Studies
Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients

NCT06068686

Sponsor

Damanhour University

Status

Completed

Last Update Posted

Feb 4, 2025Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

Vildagliptin 50 MG
Glimepiride 3 Mg Oral Tablet

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Nov 30, 2024Actual

Completion Date

Dec 1, 2024Actual

First Submitted Date

Sep 29, 2023

First Submission Date that Met QC Criteria

Sep 29, 2023

First Posted Date

Oct 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2025

Last Update Posted Date

Feb 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
All participants agreed to take part in this clinical study and provide informed consent.
Patients with uncontrolled DM type 2 who are on metformin will be enrolled from endocrinology clinic at Damanhour general hospital.
Serum samples will be collected for measuring the biomarkers.
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.
All patients will be followed up during 12 week period.
At the end of the 12 week period, serum samples will be recollected for measuring the biomarkers after treatment.
Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 12 weeks.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin 50 MG	Drug	vildagliptin plus their metformin.	Vildagliptin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rehab H Werida, Ass Prof.	Damanhour University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.		Damanhūr	Elbehairah	31527	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077597	Vildagliptin
C057619	glimepiride
D013607	Tablets

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

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.