Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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dapagliflozin

Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level.

Dapagliflozin 5Mg Tab

Intervention Type DRUG

Dapagliflozin 5mg tablets daily

glimepiride

Group 2 (n=30): are the patients who are prescribed glimepiride

Glimepiride 4Mg Tab

Intervention Type DRUG

Glimepiride Tablets daily

Interventions

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Dapagliflozin 5Mg Tab

Dapagliflozin 5mg tablets daily

Intervention Type DRUG

Glimepiride 4Mg Tab

Glimepiride Tablets daily

Intervention Type DRUG

Other Intervention Names

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Diglifloz Amaryl

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No