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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04240171

Enrollment

Registered

2020-01-27

Start date

2020-12-01

Completion date

2022-01-31

Last updated

2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DRUGDapagliflozin 5Mg Tab

Dapagliflozin 5mg tablets daily

DRUGGlimepiride 4Mg Tab

Glimepiride Tablets daily

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Blood Sugar (mg/dl)	three months	serum blood glucose
HbA1c %	three months	Glycated Hemoglobin

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026