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IRCT20221016056201N1 IRCT 2023-02-08 Arak University of Medical Sciences Effect of Linagliptin and Empagliflozine on diabetes Evaluation the effect of Linagliptin and Empagliflozin combination on glycosylated hemoglobin and fasting blood sugar control in patients with type 2 diabetes 2023-02-09 anticipated 55 Complete https://irct.ir/trial/67472 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Diabetes type 2. Intervention group: type 2 diabetic patients resistant to other oral anti-diabetic treatments (metformin, glybenclamide and acarbose) whose FBS and HbA1C are not within the therapeutic range despite regular use of these drugs. These patients receive the combination of empagliflozin and linagliptin daily for 3 months, then their FBS and HbA1C will be measured again and compared with their baseline FBS and HbA1C on the first day of the study. Patients will be taught to take one empagliflozin and linagliptin combination tablet daily during these three months and to adhere to this method of use.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is due to incomplete study information
public Mohammad Davari
Sardasht,Amir-al-momenin Hospital
Arak Iran (Islamic Republic of) 3848176941 +98 86 3836 2221 buccynator@gmail.com Arak University of Medical Sciences scientific Mohammad Davari
Sardasht,Amir-al-momenin Hospital
Arak Iran (Islamic Republic of) 3848176941 +98 86 3836 2221 buccynator@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) patients who have been diagnosed with type 2 diabetes mellitus based on the ADA diagnostic criteria and indicated for medical therapy patients who have not reached to treatment goals despite receiving previous medications no limit no limit Both type 1 diabetes pregnancy diabetic ketoacidosis (present and previous) pancreatitis (present and previous) diabetic foot ulcer (present and previous) GFR less than 30 BMI less than 18.5 severe adverse drug reactions lack of consent to participate in the study untreated urinary tract infection E11 Type 2 diabetes mellitus Treatment - Drugs Intervention group: type 2 diabetic patients resistant to other oral anti-diabetic treatments (metformin, glybenclamide and acarbose) whose FBS and HbA1C are not within the therapeutic range despite regular use of these drugs. These patients receive the combination of empagliflozin and linagliptin daily for 3 months, then their FBS and HbA1C will be measured again and compared with their baseline FBS and HbA1C on the first day of the study. Patients will be taught to take one empagliflozin and linagliptin combination tablet daily during these three months and to adhere to this method of use. Fasting blood sugar. Timepoint: beginning of the study, 3 months later. Method of measurement: blood sample. Glycosylated hemoglobin. Timepoint: beginning of the study, 3 months later. Method of measurement: blood sample. Arak University of Medical Sciences Approved 2022-04-02 Research ethics committees of Arak University of Medical Sciences Arak Univercity of Medical Science, Arak Arak Markazi Iran (Islamic Republic of)