Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Dapagliflozin 5Mg Tab; Drug: Glimepiride 4Mg Tab

• Registration Number: NCT04240171
• Lead Sponsor: Damanhour University

Brief 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.

Study Timeline

• Study First Submitted: 2019-09-15
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-27
• Study Start: 2020-12-01
• Primary Completion: 2022-01-30
• Study Completion: 2022-01-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-15
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. 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.
2. HbA1c ≥ 7

Exclusion Criteria

1. Other types of DM
2. Hypersensitivity to the drug
3. Abnormal liver function
4. Patients with renal impairment (eGFR ≤ 60 ml/min)
5. Previous history of bladder cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dapagliflozin	Dapagliflozin 5Mg Tab	Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level.
glimepiride	Glimepiride 4Mg Tab	Group 2 (n=30): are the patients who are prescribed glimepiride

Primary Outcome Measures

Name	Time	Method
Blood Sugar (mg/dl)	three months	serum blood glucose
HbA1c %	three months	Glycated Hemoglobin

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, El-Gharbia, Egypt