Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|