Comparing the effectiveness of empagliflozin with metformin in reducing blood sugar in patients with diabetes after organ transplantation
Design
This study is a parallel, double-blind, randomized clinical trial in phase 3 on 40 patients; To compare the effectiveness of empagliflozin and metformin in reducing blood sugar in patients with diabetes after transplantation. For randomization, we will use the block randomization method.
Settings and conduct
Endocrine Clinic, Dr. Masih Deneshvari Hospital, Iran, Tehran. The study is double-blind. The main researcher and the patient are not aware of the type of drug. Only the pharmacist who delivers the medicine knows the type of medicine. The pharmacist delivers both types of medicine to the patient in capsules with the same appearance
Participants/Inclusion and exclusion criteria
Inclusion Criteria :
At least 6 motnhs have passed since patinets transplant.
No previous history of Diabetes mellitus or use of any blood sugar lowering medication.
Diabetes diagnosis is done according to American Diabetes Association
6.5%<Hba1c<8%
Exclusion Criteria :
Rejection or organ failure of the transplanted organ
Pregnancy
Any contraindications of Metformin
Any contraindications of Empagliflozin
BMI above 40
Severe liver failure
Renal failure
Intervention groups
Group A participants receive empagliflozin 10 mg tablets (َIran, Tehran, Abidi
Pharmaceutical Company) for 3 months.
Group B participants receive Metformin 500 mg tablets (َIran, Alborz, Actoverco Pharmaceutical Company ) for 3 months.
Main outcome variables
HbA1c, FBS, BS 2hPP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230315057726N1
Registration date:2023-08-26, 1402/06/04
Registration timing:registered_while_recruiting
Last update:2023-08-26, 1402/06/04
Update count:0
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
Maryam Vasheghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2020
Email address
mvasheghani9@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2024-07-31, 1403/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness ofEmpagliflozin with Metformin in controlling Diabetes Mellitus in patients with post-organ transplant diabetes
Public title
Comparing the effectiveness of Empagliflozin with Metformin in controlling Diabetes Mellitus in patients with post-organ transplant diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months have passed since the patient's transplant
No previous history of diabetes and use of any blood sugar-lowering medication
Diagnosing diabetes according to the criteria of the American Diabetes Association
HbA1c< 8%
HbA1c>6.5%
Exclusion criteria:
Rejection of the transplanted organ in the patient
Transplanted organ failure
Pregnancy
Age less than 18 years
Any contraindication related to empagliflozin (allergy to the drug or its components, dialysis, diabetic ketoacidosis, hospitalization)
The patient's unwillingness to participate in the study
BMI above 40
Severe liver failure (enzymes more than 3 times the normal limit)
or renal failure (creatinine more than 2), creatinine clearance below 60
Any contraindication related to Metformin (allergy to the drug or its components, dialysis, diabetic ketoacidosis, hospitalization)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Individual
Sealed envelopes
As the numbers of each envelope are finished, the next envelope will be opened until the sample is completed. The principal investigator and the patient are unaware of the contents of the envelopes. Only the pharmacist who delivers the medicine; knows the type of medicine. The pharmacist delivers both types of medicine to the patient in capsules with the same appearance.
Blinding (investigator's opinion)
Double blinded
Blinding description
We will use block randomization to allocate the samples to intervention and control groups. For this purpose, we prepare four sheets of paper. On two sheets, we write the letter a for the treatment group of empagliflozin. Then on the other two sheets, we write the letter b for the treatment group of metformin. We mix the sheets together and put 4 sheets (two sheets with the letter A and two sheets with the letter B) in the sealed envelope. With the referral of each qualified patient, one of the sheets will be randomly drawn, and based on this drawn sheet, whether it is a or b, they will be assigned to one of the above-mentioned two groups. It should be noted that we will not refer to the next envelope until all four sheets have been pulled out. After randomly pulling out all four sheets, we go to the next sealed envelope and repeat the above procedure for the next four patients until we reach the desired sample size. The main researcher and the patient are unaware of the contents of the envelopes. Only the pharmacist who delivers the medicine knows the type of medicine. The pharmacist delivers both types of medicine to the patient in capsules with the same appearance.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad Tehran Medical Sciences University - Pharmacy and Pharmac
Street address
School of Pharmacy and Pharmaceutical Sciences - Islamic Azad University of Medical Sciences, Tehran (Research Ethics Committee), yakhchal, Qolhak, Shariati
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
IR.IAU.PS.REC.1401.374
Health conditions studied
1
Description of health condition studied
Post Transplant Diabetes Mellitus
ICD-10 code
E13
ICD-10 code description
Other specified diabetes mellitus
Primary outcomes
1
Description
HbA1c
Timepoint
To compare the effectiveness of two drugs, empagliflozin and metformin, HbA1C of patients with Post Transplant Diabetes Mellitus(PTDM) is measured at the beginning of the study and 90 days after taking the drug.
Method of measurement
Blood Sample
Secondary outcomes
1
Description
FBS (fasting blood sugar)
Timepoint
To compare the effectiveness of two drugs, empagliflozin and metformin, FBS of patients with Post Transplant Diabetes Mellitus(PTDM) is measured at the beginning of the study and 90 days after taking the drug.
Method of measurement
Blood Sample
Intervention groups
1
Description
Intervention group A: Empagliflozin 10mg(َIran, Tehran, Abidi Pharmaceutical Company) for 3 months.
Category
Treatment - Drugs
2
Description
Intervention groupB: Metformin 500 mg(َIran, Alborz, Actoverco Pharmaceutical Company ) for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih daneshavari hosrpital
Full name of responsible person
Maryam Vasheghani
Street address
Darbad , Niyavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2020
Email
mvasheghani9@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Rajabi
Street address
Yakhchal St., Qolhak, Dr.Shariati Blvd.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
lnt.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Amirhossein niknejad
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 6, Ravanpour St., Jordan Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1966874513
Phone
+98 21 2202 3410
Email
amirhosseinniknejad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Vasheghani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Darabad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2020
Email
mvasheghani9@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Vasheghani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Darabad, Niavaran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2020
Email
mvasheghani9@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Title and more details about the data/document
All project implementers have access to the data
When the data will become available and for how long
whole study time
To whom data/document is available
All project implementers
Under which criteria data/document could be used
The data is published together and without mentioning the name
From where data/document is obtainable
The chief investigator
Dr. Maryam Vasheghani
mvasheghani9@sbmu.ac.ir
Amirhossein Niknejad
amirhosseinniknejad@gmail.com
What processes are involved for a request to access data/document
The applicants must send their request via E-Mail to the aforementioned researchers, and after the review and approval of the ethics committee of Islamic Azad University of Medical Sciences, the information will be provided to the applicant to the extent necessary without mentioning the names of patients.
Comments
The data is published together and without mentioning the name