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IRCT20191126045505N1 IRCT 2020-01-06 Bojnourd University of Medical Sciences Effects of empagliflozin in diabetes treatment The effects of empagliflozin on neuropathy and retinopathy outcomes, renal function, and quality of life in patients with type 2 diabetes in Bojnurd 2021-06-22 anticipated 100 Complete https://irct.ir/trial/44017 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 description: In this study, participants and researchers (therapist) are not aware of the type of intervention for each patient. 3 type II Diabetes. Intervention 1: 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). Intervention 2: 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). Yes - There is a plan to make this available What will be shared: 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: 6 months after publishing the results To whom: Researchers working in academia and in the industries Conditions: Any analysis and use of the data and documentation submitted will be conditional with informing project executor and her consent. Where to obtain: Refer to Dr. Habieh Sadat Shakeri, principal Executor, for the documentation. Email: drhssh@yahoo.com Affiliations: Faculty of Medicine, Bojnourd University of Medical Sciences How to obtain: 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: -
public Habibeh Sadat Shakeri
Educational, Research and Medical Center of Imam Hasan, Pardis town, Bojnurd, North khorasan
Bojnurd Iran (Islamic Republic of) 74877-94149 +98 58 3151 0000 drhssh@yahoo.com Bojnourd University of Medical Sciences scientific Habibeh Sadat Shakeri
Educational, Research and Medical Center of Imam Hasan, Pardis town, Bojnurd, North Khorasan
Bojnurd Iran (Islamic Republic of) 74877-94149 +98 58 3151 0000 drhssh@yahoo.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 E11 Type 2 diabetes mellitus Placebo Treatment - Drugs 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). 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). Evaluation of glycated hemoglobin or long-term blood sugar. Timepoint: Weeks 0 and 24. Method of measurement: Using the laboratory kit. Fasting blood sugar measurement. Timepoint: Weeks 0 and 24. Method of measurement: Using the laboratory kit. Measurement of glomerular filtration level for indirect evaluation of kidney status. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit. Measurement of urine albumin concentration. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit. Urine creatinine measurement. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit. Measurement of changes in urinary albumin / creatinine ratio. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit. Evaluation of aspartate aminotransferase level for evaluation of liver function. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit. Evaluation of alanine aminotransferase level for evaluation of liver function. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit. Measurement of blood alkaline phosphatase level for evaluation of hepatic function. Timepoint: weeks 0 and 24. Method of measurement: Using the laboratory kit. Patient quality of life. Timepoint: Weeks 0 and 24. Method of measurement: DQOL questionnaire. 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. Neuropathy examinations. Timepoint: Weeks 0 and 24. Method of measurement: Pain score changes, EMG and NCV. Bojnourd University of Medical Sciences Approved 2019-11-03 Ethics Committee for Research of North Khorasan University of Medical Sciences Central Building of North Khorasan University of Medical Sciences, Dolat Boulevard, Bojnourd Bojnurd North Khorasan Iran (Islamic Republic of)