Comparison the effects of Empaglifluzin-linagliptin and Dapaglifluzin-linagliptin on HbA1c ، LDL and Albuminuria in patients with T2DM

If the results of this study can show the effect of one of the two drugs on reducing HbA1c, LDL and albuminuria better than the other drug, that drug can be used as the preferred drug for treating diabetes complications and also reducing blood sugar.

Randomized parallel clinical trial, single blind, randomized, phase 2 on 70 patients. Randomized block permutation method will be used for randomization.

The randomized clinical trial is aligned and the two groups remain constant in terms of intervention until the end of the study. Information will be collected in the outpatient clinics of Amir al-Mominin and Imam Reza Arak hospitals and within 3 months after obtaining the code of ethics. The study is one-sided blind. 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 treatment group codes to which the patients belong.

Age above 30 and less than 75 years. Having type 2 diabetes. Glycosylated hemoglobin higher than 7.5 and less than 11. Has albuminuria. No acute hospitalization conditions. Not taking medication beforehand.

Intervention is done in both groups. Empagliflozin-linagliptin is given to one group and dapagliflozin-linagliptin to the other group once a day for three months.

The main outcome of this study is urine microalbuminuria, which is considered as the main indicator of diabetic nephropathy, HbA1c and LDL. It is evaluated by urine and blood samples at the beginning of the study, three months after the start of the treatment.

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.

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.