Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

April 15, 2023 updated by: Rehab Werida, Damanhour University

Comparative Study of Dapagliflozin Versus Glimepiride Effect on Insulin Regulated Aminopeptidase (IRAP) and Interleukin-34 (IL-34) in Patient With Type 2 Diabetes Mellitus

Research objectives:

The aim of the study to check the effect of Dapagliflozin versus Glimepiride on insulin regulated aminopeptidase (IRAPe), NT-Pro BNP and interleukin-34 (IL-34) in patients with type 2 diabetes mellitus, and associated it with insulin resistance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Method and proposal steps:

  1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
  2. All participant agreed to take part in this clinical study and provide informed consent.
  3. 60 Patients with type 2 DM will be enrolled Internal Medicine Department, Tanta University Hospital.
  4. Serum samples will be collected for measuring the biomarkers.
  5. All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. Group 2 (n=30): are the patients who are prescribed glimepiride
  6. All patients will be followed up during 3 months' period.
  7. At the end of 3 months, step 4 will be repeated.
  8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
  9. Measuring outcomes: the primary outcome is the change from baseline to post-treatment insulin sensitivity reflected by change of serum level of measured marker after 3 months.
  10. Results, discussion, conclusion, and recommendations will be given.

Methodology:

  1. Fasting blood glucose (FBG) 2 hrs. post prandial blood glucose(2hPPBG) will be measured by glucometer.
  2. HbA1c %, Fasting plasma insulin (FPI), Interleukin-34 (IL-34), NT-Pro BNP and extracellular domain of insulin regulated aminopeptidase (IRAPe) will be assayed by Enzyme-Linked Immunosorbent Assay (ELISA).
  3. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

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

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta university hospital

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

3- 60 Patients with type 2 DM will be enrolled Internal Medicine Department, Tanta University Hospital.

4- Serum samples will be collected for measuring the biomarkers. All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. Group 2 (n=30): are the patients who are prescribed glimepiride

  • All patients will be followed up during 3 months' period.
  • At the end of 3 months, step 4 will be repeated.

Description

Inclusion Criteria:

  1. 60 Patients with type 2 DM diagnosed clinically. The age ranged from 18 to 70 years. There are no limits to the duration of DM and gender.
  2. HbA1c ≥ 7

Exclusion Criteria:

  1. Other types of DM
  2. Hypersensitivity to the drug
  3. Abnormal liver function
  4. Patients with renal impairment (eGFR ≤ 60 ml/min)
  5. Previous history of bladder cancer

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
dapagliflozin
Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level.
Drug: Dapagliflozin 5Mg Tab
Dapagliflozin 5mg tablets daily
Other Names:
  • Diglifloz
glimepiride
Group 2 (n=30): are the patients who are prescribed glimepiride
Drug: Glimepiride 4Mg Tab
Glimepiride Tablets daily
Other Names:
  • Amaryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Sugar (mg/dl)
Time Frame: three months
serum blood glucose
three months
HbA1c %
Time Frame: three months
Glycated Hemoglobin
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NT-Pro BNP (ng/ml)
Time Frame: Three Months
Natriuretic peptide tests measure levels of BNP or NT-proBNP in the blood.
Three Months
IRAPe (ng/ml)
Time Frame: Three Months
extracellular part of insulin-regulated aminopeptidase (IRAPe).
Three Months
IL-34 (pg./ml)
Time Frame: Three Months
interleukin (IL)-34.
Three Months

Collaborators and Investigators

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

Sponsor

Damanhour University

Collaborators

Tanta University

Investigators

  • Study Chair: Nashwa EL-Gharabawy, Lecturer, Tanta University
  • Study Director: Rehab Werida, Damanhour University, Faculty of Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2020

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

September 15, 2019

First Submitted That Met QC Criteria

January 21, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 15, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dapagliflozin in T2DM

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

product manufactured in and exported from the U.S.

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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