Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational [Patient Registry]

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.
    

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.
    

Intervention name(s): Dapagliflozin 5Mg Tab; Glimepiride 4Mg Tab
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin 5mg tablets daily; Glimepiride Tablets daily
Other intervention name(s): Diglifloz; Amaryl
Intervention MeSH terms: Dapagliflozin; Glimepiride
Observational model: Case-Control
Time perspective: Prospective
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.