To compare the incidence of urinary tract infections in women with diabetes treated with empagliflozin or dapagliflozin, in order to determine which drug has a better safety profile in this regard.
Design
Clinical trial with two parallel groups treated with diabetes drugs dapagliflozin and empagliflozin on 84 patients; randomized, double-blind study, analyzed using SPSS or SAS statistical software.
Settings and conduct
Convenience sampling will be used. Women with diabetes who refer to Imam Reza Hospital in Tehran will be identified and placed in study groups. Participants will be randomly divided into two groups treated for diabetes with dapagliflozin and empagliflozin. The study is a double-blind, randomized study, and patients and investigators will not be informed of the research.
Participants/Inclusion and exclusion criteria
Statistical population: Women with diabetes.
Selection criteria: Women with diabetes (type 1 or 2).
Agreement to participate in the study and take the study medications.
No physical or psychological barriers to active participation in the study.
Women over 18 years of age; Exclusion criteria: intolerance or negative reaction to the study medications; serious side effects from the medications; pregnancy.
Intervention groups
Women with diabetes will be divided into two groups. Participants will be prescribed the study drug (empagliflozin and dapagliflozin); periodic follow-ups will be conducted (after three months) to assess the effect of the drugs on the rate of urinary tract infections.
Main outcome variables
Incidence of confirmed urinary tract infection (UTI) in diabetic women treated with empagliflozin compared with dapagliflozin
General information
Reason for update
Acronym
TDS
IRCT registration information
IRCT registration number:IRCT20250129064554N1
Registration date:2025-04-15, 1404/01/26
Registration timing:registered_while_recruiting
Last update:2025-04-15, 1404/01/26
Update count:0
Registration date
2025-04-15, 1404/01/26
Registrant information
Name
sara kazm nadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4420 6090
Email address
saranadi1402@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-11, 1403/07/20
Expected recruitment end date
2025-06-26, 1404/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of empagliflozin and dapagliflozin in the incidence of urinary tract infection in women with diabetes
Public title
Comparison of two drugs, empagliflozin and dapagliflozin, in the development of urinary tract infections in women with high blood sugar
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women with diabetes (type 1 or 2)
Women over 18 years of age
No physical or psychological barriers to active participation in the study.
Consent to participate in the study and take the study medication.
Exclusion criteria:
Intolerance or adverse reaction to the study drugs.
Having serious side effects from the drugs.
Being pregnant
Age
From 18 years old
Gender
Female
Phase
4
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
84
More than 1 sample in each individual
Number of samples in each individual:
2
Necessary tests are performed to measure the variables under investigation. This includes urine test results to assess the level of urinary tract infection before and after receiving the medication.
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned to different groups. For this purpose, patients referring to the treatment center are divided into two groups without knowledge: those treated for diabetes with the drug dapagliflozin and those treated with the drug empagliflozin. In order to be more confident in deducing the results of the randomized double-blind study, patients and investigators (those who perform the urine infection test, complications, and effectiveness of the drugs) are not informed of the research.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to be more confident in drawing conclusions from the results of a randomized double-blind study, patients and investigators (those who test for urinary tract infections, complications, and the effectiveness of medications) are not informed of the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Republic of Iran Army University of Medical Sciences
Street address
AJA university of medical sciences, Etemad zadeh street, Fatemi Gharbi street
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۸۵۴۱
Approval date
2024-10-02, 1403/07/11
Ethics committee reference number
IR.AJAUMS.REC.1403.153
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people who get urinary tract infections.
Timepoint
Three months after taking the drugآ
Method of measurement
Urinalysis and urine culture test
Secondary outcomes
1
Description
Percentage of people who experience drug side effects.
Timepoint
Three months after taking the medication
Method of measurement
Urinalysis and urine culture
2
Description
Percentage of people whose blood sugar is controlled with the study drugs.
Timepoint
Three months after taking the medication
Method of measurement
Urinalysis and urine culture
Intervention groups
1
Description
Intervention group:Empagliflozin.
Category
Prevention
2
Description
Intervention group:Dapagliflozin.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital (AS) 501 Aja
Full name of responsible person
Sara kazemnadi
Street address
AJA university of medical sciences, Etemad zadeh street, Fatemi Gharbi street
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۸۵۴۱
Phone
+98 21 8609 6350
Fax
+98 21 8609 6350
Email
saranadi1402@gmail.com
Web page address
https://imamreza.ajaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Mosaed
Street address
AJA university of medical sciences, Etemad zadeh street, Fatemi Gharbi street
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۸۵۴۱
Phone
+98 21 8609 6350
Fax
+98 21 8609 6350
Email
Reza.mosaed@ajaums.ac.ir
Web page address
https://www.ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
5
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sarah Keshkari
Position
Assistant Professor, Army University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
AJA university of medical sciences, Etemad zadeh street, Fatemi Gharbi street
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۸۵۴۱
Phone
+98 21 8609 6350
Fax
+98 21 8609 6350
Email
Skeshtkari1@gmail.com
Web page address
https://jps.ajaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyyed Vahid Mousavi
Position
Assistant Professor, Army University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
AJA university of medical sciences, Etemad zadeh street, Fatemi Gharbi street
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۸۵۴۱
Phone
+98 21 8609 6350
Fax
+98 21 8609 6350
Email
drsv.mousavi@gmail.com
Web page address
https://www.ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sarah Kazem Nadi
Position
Internal Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
AJA university of medical sciences, Etemad zadeh street, Fatemi Gharbi street
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۸۵۴۱
Phone
+98 21 8609 6350
Fax
+98 21 8609 6350
Email
saranadi1402@gmail.com
Web page address
https://www.ajaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available