Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT04240171|
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : June 25, 2020
The aim of the study to check the effect of Dapagliflozin versus Glimepiride on insulin regulated aminopeptidase (IRAPe) and interleukin-34 (IL-34) in patients with type 2 diabetes mellitus, and associated it with insulin resistance.
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Drug: Dapagliflozin 5Mg Tab Drug: Glimepiride 4Mg Tab|
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.
- 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), 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||60 participants|
|Target Follow-Up Duration:||3 Months|
|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|
|Estimated Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
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 Name: Diglifloz
Group 2 (n=30): are the patients who are prescribed glimepiride
Drug: Glimepiride 4Mg Tab
Glimepiride Tablets daily
Other Name: Amaryl
- Blood Sugar [ Time Frame: three months ]serum blood glucose
- HbA1c % [ Time Frame: three months ]Glycated Hemoglobin
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240171
|Contact: Rehab Werida, Lectureremail@example.com|
|Contact: Nashwa EL-Gharabawy, Lecturerfirstname.lastname@example.org|
|Tanta University Hospital|
|Tanta, El-Gharbia, Egypt, 31527|
|Study Chair:||Nashwa EL-Gharabawy, Lecturer||Tanta University|
|Study Director:||Rehab Werida||Damanhour University, Faculty of Pharmacy|