- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04240171
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Methodology:
- 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), NT-Pro BNP 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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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. 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.
Description
Inclusion Criteria:
- 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.
- HbA1c ≥ 7
Exclusion Criteria:
- Other types of DM
- Hypersensitivity to the drug
- Abnormal liver function
- Patients with renal impairment (eGFR ≤ 60 ml/min)
- Previous history of bladder cancer
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
dapagliflozin
Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level.
|
Dapagliflozin 5mg tablets daily
Other Names:
|
glimepiride
Group 2 (n=30): are the patients who are prescribed glimepiride
|
Glimepiride Tablets daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Sugar (mg/dl)
Time Frame: three months
|
serum blood glucose
|
three months
|
HbA1c %
Time Frame: three months
|
Glycated Hemoglobin
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NT-Pro BNP (ng/ml)
Time Frame: Three Months
|
Natriuretic peptide tests measure levels of BNP or NT-proBNP in the blood.
|
Three Months
|
IRAPe (ng/ml)
Time Frame: Three Months
|
extracellular part of insulin-regulated aminopeptidase (IRAPe).
|
Three Months
|
IL-34 (pg./ml)
Time Frame: Three Months
|
interleukin (IL)-34.
|
Three Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Nashwa EL-Gharabawy, Lecturer, Tanta University
- Study Director: Rehab Werida, Damanhour University, Faculty of Pharmacy
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Immunosuppressive Agents
- Immunologic Factors
- Sodium-Glucose Transporter 2 Inhibitors
- Dapagliflozin
- Glimepiride
Other Study ID Numbers
- Dapagliflozin in T2DM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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