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Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

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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

Tracking Information
First Submitted Date September 15, 2019
First Posted Date January 27, 2020
Last Update Posted Date June 25, 2020
Estimated Study Start Date August 1, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2020)
  • Blood Sugar [ Time Frame: three months ]
    serum blood glucose
  • HbA1c % [ Time Frame: three months ]
    Glycated Hemoglobin
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus
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
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.

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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
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.
Condition Diabetes Mellitus, Type 2
Intervention
  • Drug: Dapagliflozin 5Mg Tab
    Dapagliflozin 5mg tablets daily
    Other Name: Diglifloz
  • Drug: Glimepiride 4Mg Tab
    Glimepiride Tablets daily
    Other Name: Amaryl
Study Groups/Cohorts
  • dapagliflozin
    Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level.
    Intervention: Drug: Dapagliflozin 5Mg Tab
  • glimepiride
    Group 2 (n=30): are the patients who are prescribed glimepiride
    Intervention: Drug: Glimepiride 4Mg Tab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 21, 2020)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rehab Werida, Lecturer +201005359968 rehabwrieda@pharm.dmu.edu.eg
Contact: Nashwa EL-Gharabawy, Lecturer nashwa.elgharbawy@med.tanta.edu.eg
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04240171
Other Study ID Numbers Dapagliflozin in T2DM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rehab Werida, Damanhour University
Study Sponsor Damanhour University
Collaborators Tanta University
Investigators
Study Chair: Nashwa EL-Gharabawy, Lecturer Tanta University
Study Director: Rehab Werida Damanhour University, Faculty of Pharmacy
PRS Account Damanhour University
Verification Date June 2020