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IRCT20221221056889N1 IRCT 2023-02-23 Arak University of Medical Sciences Comparison the effects of Empaglifluzin-linagliptin and Dapaglifluzin-linagliptin on HbA1c ، LDL and Albuminuria in patients with T2DM Comparison the effects of Empaglifluzin-linagliptin and Dapaglifluzin-linagliptin on HbA1c ، LDL and Albuminuria in patients with T2DM 2023-03-06 anticipated 70 Complete https://irct.ir/trial/68691 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, permutation random block method will be used for randomization. For this purpose, a block of 6 will be used. In each block, the letter E is written on 3 cards and the letter D is written on 3 cards. The random blocks of 6 chosen are as follows: ,DEDDEE,DEEDDE,EDEDED,DEEDDE,EEDEDD,EDEDDE .EDDE, DEDDEE, EEDEDD, EDDEED, DEEDDE, EDDDEE (For example, the method of random assignment in EDEDDE block of 6 is as follows: the first patient to treatment E, the second patient to treatment D, the third patient to treatment E, the fourth patient to treatment D, the fifth patient to treatment D, and the sixth patient to Treatment E is randomly assigned.) The purpose of randomization is to create homogenous groups, so by randomizing, groups will be formed that are similar to a large extent in terms of many influencing characteristics, and the only factor that differs between groups is the treatment that they have been randomly assigned to, and thus it can be He said that the result observed in each group is the effect of that drug and in fact the effectiveness of the drug can be estimated, Blinding description: This study is single-blind. In this way, the researcher and the patient know about the received treatment and there is no possibility of blinding them, but in order to prevent bias in the analysis, the analyst will not know about the codes of the treatment group to which the patients belong. N/A Type 2 diabetes. First intervention group: empagliflozin-linagliptin drug 5-10 mg daily and one tablet per day for three months. The second intervention group: dapagliflozin-linagliptin 5-10 mg daily, one tablet per day for three months.. 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 Sampling has not started
public Saeed seyedi niasar
Sardasht - Basij Square - Amirul Mominin Hospital - internal group training
Arak Iran (Islamic Republic of) 3848176941 +98 86 3836 0000 sseyedi43@gmail.com Arak University of Medical Sciences scientific Saeed seyedi niasar
Sardasht - Basij Square - Amirul Mominin Hospital
Arak Iran (Islamic Republic of) 3848176941 +98 86 3836 0000 sseyedi43@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Having type 2 diabetes Hb A1c above 7 and below 11 No acute hospitalization conditions Age between 30 and 75 years Patients with albuminuria Not taking the drug beforehand 30 years 75 years Both Acute hospitalization conditions Pre-medication Treatment - Drugs First intervention group: empagliflozin-linagliptin drug 5-10 mg daily and one tablet per day for three months. The second intervention group: dapagliflozin-linagliptin 5-10 mg daily, one tablet per day for three months. The main outcome of this study is urine microalbuminuria, which is considered as the main indicator of diabetic nephropathy, LDL and HbA1c. This result is evaluated by spot urine and blood samples at the beginning of the study, three months after the start of the treatment. Timepoint: At the beginning of the study and three months after the start of treatment. Method of measurement: It is evaluated by spot urine and blood samples at the beginning of the study and three months after the start of the treatment. Other outcomes included in the researcher's checklist (attached at the end of the proposal), such as FBS, GFR, and lipid profile, are evaluated by the patient's blood test at the beginning of the study, and after the completion of the treatment period, i.e., three months after the start of the treatment. Timepoint: The beginning of the study and three months after the start of treatment. Method of measurement: By testing the patient's blood. Arak University of Medical Sciences Approved 2022-12-25 Ethics Committee of Arak University of Medical Sciences sardasht Arak Markazi Iran (Islamic Republic of)