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Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

Sponsor
Damanhour University (Other)
Overall Status
Completed
CT.gov ID
NCT04240171
Collaborator
Tanta University (Other)
60
Enrollment
1
Location
14
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dapagliflozin 5Mg Tab
  • Drug: Glimepiride 4Mg Tab

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparative Study of Dapagliflozin Versus Glimepiride Effect on Insulin Regulated Aminopeptidase (IRAP) and Interleukin-34 (IL-34) in Patient With Type 2 Diabetes Mellitus
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Jan 30, 2022
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Blood Sugar (mg/dl) [three months]

      serum blood glucose

    2. HbA1c % [three months]

      Glycated Hemoglobin

    Secondary Outcome Measures

    1. NT-Pro BNP (ng/ml) [Three Months]

      Natriuretic peptide tests measure levels of BNP or NT-proBNP in the blood.

    2. IRAPe (ng/ml) [Three Months]

      extracellular part of insulin-regulated aminopeptidase (IRAPe).

    3. IL-34 (pg./ml) [Three Months]

      interleukin (IL)-34.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Hospital Tanta El-Gharbia Egypt 31527

    Sponsors and Collaborators

    • Damanhour University
    • Tanta University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rehab Werida, Clinical Pharmacy Lecturer, Damanhour University
    ClinicalTrials.gov Identifier:
    NCT04240171
    Other Study ID Numbers:
    • Dapagliflozin in T2DM
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    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:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Dapagliflozin
    Glimepiride

    Study Results

    No Results Posted as of Aug 15, 2022