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Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240171
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Rehab Werida, Damanhour University

Brief Summary:

Research objectives:

The aim of the study to check the effect of Dapagliflozin versus Glimepiride on insulin regulated aminopeptidase (IRAPe) and interleukin-34 (IL-34) in patients with type 2 diabetes mellitus, and associated it with insulin resistance.


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Dapagliflozin 5Mg Tab Drug: Glimepiride 4Mg Tab

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), 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
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
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
dapagliflozin
Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level.
Drug: Dapagliflozin 5Mg Tab
Dapagliflozin 5mg tablets daily
Other Name: Diglifloz

glimepiride
Group 2 (n=30): are the patients who are prescribed glimepiride
Drug: Glimepiride 4Mg Tab
Glimepiride Tablets daily
Other Name: Amaryl




Primary Outcome Measures :
  1. Blood Sugar [ Time Frame: three months ]
    serum blood glucose

  2. HbA1c % [ Time Frame: three months ]
    Glycated Hemoglobin



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240171


Contacts
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Contact: Rehab Werida, Lecturer +201005359968 rehabwrieda@pharm.dmu.edu.eg
Contact: Nashwa EL-Gharabawy, Lecturer nashwa.elgharbawy@med.tanta.edu.eg

Locations
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Egypt
Tanta University Hospital
Tanta, El-Gharbia, Egypt, 31527
Sponsors and Collaborators
Damanhour University
Tanta University
Investigators
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Study Chair: Nashwa EL-Gharabawy, Lecturer Tanta University
Study Director: Rehab Werida Damanhour University, Faculty of Pharmacy
Publications of Results:
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Responsible Party: Rehab Werida, Clinical Pharmacy Lecturer, Damanhour University
ClinicalTrials.gov Identifier: NCT04240171    
Other Study ID Numbers: Dapagliflozin in T2DM
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Glimepiride
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors