Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Dapagliflozin 5Mg Tab
* Drug: Glimepiride 4Mg Tab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dapagliflozin<br>Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. | Drug: Dapagliflozin 5Mg Tab<br>* Dapagliflozin 5mg tablets daily<br>* Other names: Diglifloz;|
| glimepiride<br>Group 2 (n=30): are the patients who are prescribed glimepiride | Drug: Glimepiride 4Mg Tab<br>* Glimepiride Tablets daily<br>* Other names: Amaryl;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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