Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04240171
• Other study ID #: Dapagliflozin in T2DM
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2023
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dapagliflozin 5Mg Tab
Dapagliflozin 5mg tablets daily
• Glimepiride 4Mg Tab
Glimepiride Tablets daily

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	El-Gharbia

Sponsors (2)

Lead Sponsor	Collaborator
Damanhour University	Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Abdul-Ghani MA, Norton L, DeFronzo RA. Renal sodium-glucose cotransporter inhibition in the management of type 2 diabetes mellitus. Am J Physiol Renal Physiol. 2015 Dec 1;309(11):F889-900. doi: 10.1152/ajprenal.00267.2015. Epub 2015 Sep 9. — View Citation

Davidson JA, Kuritzky L. Sodium glucose co-transporter 2 inhibitors and their mechanism for improving glycemia in patients with type 2 diabetes. Postgrad Med. 2014 Oct;126(6):33-48. doi: 10.3810/pgm.2014.10.2819. — View Citation

Monami M, Nardini C, Mannucci E. Efficacy and safety of sodium glucose co-transport-2 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2014 May;16(5):457-66. doi: 10.1111/dom.12244. Epub 2013 Dec 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Sugar (mg/dl)	serum blood glucose	three months
Primary	HbA1c %	Glycated Hemoglobin	three months
Secondary	NT-Pro BNP (ng/ml)	Natriuretic peptide tests measure levels of BNP or NT-proBNP in the blood.	Three Months
Secondary	IRAPe (ng/ml)	extracellular part of insulin-regulated aminopeptidase (IRAPe).	Three Months
Secondary	IL-34 (pg./ml)	interleukin (IL)-34.	Three Months