Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

Method and proposal steps:

• Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
• All participant agreed to take part in this clinical study and provide informed consent.
• 60 Patients with type 2 DM will be enrolled Internal Medicine Department, Tanta University Hospital.
• 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.
• Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
• 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.
• Results, discussion, conclusion, and recommendations will be given.

Methodology:

• Fasting blood glucose (FBG) 2 hrs. post prandial blood glucose(2hPPBG) will be measured by glucometer.
• 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).
• Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated.

Inclusion criteria

• 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.
• HbA1c ≥ 7

Exclusion criteria

• Other types of DM
• Hypersensitivity to the drug
• Abnormal liver function
• Patients with renal impairment (eGFR ≤ 60 ml/min)
• Previous history of bladder cancer