NCT04240171

Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Dapagliflozin 5Mg Tab	Dapagliflozin 5mg tablets daily
DRUG	Glimepiride 4Mg Tab	Glimepiride Tablets daily

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-01-30
• Completion: 2022-01-31
• First posted: 2020-01-27
• Last updated: 2023-04-18

Locations

1 site across 1 country: Egypt