Protocol summary
-
Study aim
-
The effect of empagliflozin on renal, retinopathy, neuropathy outcomes, and quality of life in type 2 diabetics
-
Design
-
This study is a randomized double blind clinical trial study. Patients in the study were randomly divided into two groups receiving empagliflozin at 10 mg daily or placebo . Under special circumstances, the patient will receive emergency treatment. When the patient's hyperglycemia or hypoglycemia is uncontrollable, the patient is excluded. The allocation of patients to each of the study groups will be stratified randomly. According to the HbA1c index, patients are initially divided into two groups greater than 8.5 mg/dl and less than 8.5 mg/dl. Then, the required volume in each group is randomly assigned to each group. Randomization is done using a computer. The code of each intervention is kept confidential and given to the therapist by the clinic secretary to ensure the correct allocation is made randomly. The duration of treatment will be 24 weeks. At the beginning and end of the study, the target variables of the study will be examined. Patients will also be evaluated for side effects of the drug
-
Settings and conduct
-
The study population will be patients with type 2 diabetes referred to endocrinologist office in Bojnourd.
In this study, the therapist, patients, and the individual analyzing the results are blinded to the allocation of patints into two groups.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Type 2 diabetic patients known for at least 6 months
Exclusion criteria: eGFR less than 45, liver failure, type 1 diabetes, severe cardiovascular problems in the last three months, pregnancy and lactation.
-
Intervention groups
-
Case group: Empagliflozin recipient
Control group: placebo recipient
-
Main outcome variables
-
Glycemic indexes, liver and kidney functions, retinopathy and neuropathy complications, pain score, and quality of life
General information
-
Reason for update
-
Adding a few other outcomes following the administration of empagliflozin (quality of life)
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20191126045505N1
Registration date:
2020-01-06, 1398/10/16
Registration timing:
prospective
Last update:
2023-07-10, 1402/04/19
Update count:
2
-
Registration date
-
2020-01-06, 1398/10/16
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-06-22, 1400/04/01
-
Expected recruitment end date
-
2021-10-22, 1400/07/30
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effects of empagliflozin on neuropathy and retinopathy outcomes, renal function, and quality of life in patients with type 2 diabetes in Bojnurd
-
Public title
-
Effects of empagliflozin in diabetes treatment
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Type 2 diabetic patients who have been diagnosed for at least 6 months and treated at least with two anti-diabetic drugs.
7<HbA1c>10
BMI= Kg/m245
Exclusion criteria:
EGFR<45
Liver Failure
Type1 diabetes
History of ketosis
History of frequent falls and recurrent infections
Significant renal disease requiring dialysis
Inappropriate drug use
Serious medical conditions such as severe cardiovascular disease such as heart attack or stroke in the last three months
Blood pressure above 180/110 mmHg
Major surgery performed in the last 28 days
Cancer treatment in the past 5 years
Receiving systemic glucocorticoids
Alcohol or substance abuse
Pregnancy and lactation
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
100
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
patients will be allocated to each group stratified randomly. According to the HbA1c index, patients are first divided into<5.8 and>5.8. Then, the required volume in each group (50 people) is randomly selected from the category.Randomization is done using a computer. For the purpose of the random assignment correctly, the code of any intervention is kept confidential by the secretary of the clinic regardless the patients' condition. Then, these envelopes are sealed and is giving to the specialist who will assign each patient to one of the intervention groups.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
In this study, participants and researchers (therapist) are not aware of the type of intervention for each patient.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-11-03, 1398/08/12
-
Ethics committee reference number
-
IR.NKUMS.REC.1398.096
Health conditions studied
1
-
Description of health condition studied
-
type II Diabetes
-
ICD-10 code
-
E11
-
ICD-10 code description
-
Type 2 diabetes mellitus
Primary outcomes
1
-
Description
-
Evaluation of glycated hemoglobin or long-term blood sugar
-
Timepoint
-
Weeks 0 and 24
-
Method of measurement
-
Using the laboratory kit
2
-
Description
-
Fasting blood sugar measurement
-
Timepoint
-
Weeks 0 and 24
-
Method of measurement
-
Using the laboratory kit
3
-
Description
-
Measurement of glomerular filtration level for indirect evaluation of kidney status
-
Timepoint
-
weeks 0 and 24
-
Method of measurement
-
Using the laboratory kit
4
-
Description
-
Measurement of urine albumin concentration
-
Timepoint
-
weeks 0 and 24
-
Method of measurement
-
Using the laboratory kit
5
-
Description
-
Urine creatinine measurement
-
Timepoint
-
weeks 0 and 24
-
Method of measurement
-
Using the laboratory kit
6
-
Description
-
Measurement of changes in urinary albumin / creatinine ratio
-
Timepoint
-
weeks 0 and 24
-
Method of measurement
-
Using the laboratory kit
7
-
Description
-
Evaluation of aspartate aminotransferase level for evaluation of liver function
-
Timepoint
-
weeks 0 and 24
-
Method of measurement
-
Using the laboratory kit
8
-
Description
-
Evaluation of alanine aminotransferase level for evaluation of liver function
-
Timepoint
-
weeks 0 and 24
-
Method of measurement
-
Using the laboratory kit
9
-
Description
-
Measurement of blood alkaline phosphatase level for evaluation of hepatic function
-
Timepoint
-
weeks 0 and 24
-
Method of measurement
-
Using the laboratory kit
10
-
Description
-
Patient quality of life
-
Timepoint
-
Weeks 0 and 24
-
Method of measurement
-
DQOL questionnaire
11
-
Description
-
Retinopathy studies
-
Timepoint
-
Weeks 0 and 24
-
Method of measurement
-
Measurement of central macular thickness, corrected visual acuity, thickness of retinal and central subcutaneous tissue
12
-
Description
-
Neuropathy examinations
-
Timepoint
-
Weeks 0 and 24
-
Method of measurement
-
Pain score changes, EMG and NCV
Intervention groups
1
-
Description
-
The participants receiving placebo at a dose of 10 mg per day for three months (in the morning and with water) or placebo, in combination with the patient's previous medications, including metformin. , sulfonylurea and non-sulfonylurea (with the maximum tolerated dose or the maximum dose based on the drug label) will be allocated. Medicines prescribed to patients (empagliflozin tablets and placebo) are prepared in the form of tablets of the same shape. The drug is prepared in the exact same way as empagliflozin produced in َAbidi factory and by the order of the same company (with the cooperation of the scientific representative of this company).
-
Category
-
Placebo
2
-
Description
-
Intervention group: The participants receiving empagliflozin at a dose of 10 mg per day for three months (in the morning and with water)in combination with the patient's previous medications, including metformin. , sulfonylurea and non-sulfonylurea (with the maximum tolerated dose or the maximum dose based on the drug label) will be allocated. Medicines prescribed to patients ( placebo) are prepared in the form of tablets of the same shape. The drug is prepared in the exact same way as empagliflozin produced in َAbidi factory and by the order of the same company (with the cooperation of the scientific representative of this company).
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Bojnourd University of Medical Sciences
-
Proportion provided by this source
-
100
-
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
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
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is 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
-
At the end of the study and after the results are published, information about the study protocol, how to analyze the data, and the main outcomes are shared.
-
When the data will become available and for how long
-
6 months after publishing the results
-
To whom data/document is available
-
Researchers working in academia and in the industries
-
Under which criteria data/document could be used
-
Any analysis and use of the data and documentation submitted will be conditional with informing project executor and her consent.
-
From where data/document is obtainable
-
Refer to Dr. Habieh Sadat Shakeri, principal Executor, for the documentation.
Email: drhssh@yahoo.com
Affiliations: Faculty of Medicine, Bojnourd University of Medical Sciences
-
What processes are involved for a request to access data/document
-
The applicant should send an application to Dr. Habieh Sadat Shaker by email and she will respond as soon as possible after reviewing and consulting with other project members.
-
Comments
-
-