Comparison of the Effect of Empaglifluzin and Linagliptin on the Albuminuria of patients with diabetes mellitus type 2 patients

Comparison of the mean amount of albuminuria between the group receiving Empagliflozin with the group receiving Linagliptin at the beginning and end of the study

This study is a double blind clinical trial in which 60 patients in two groups receive a random code, which corresponds to the numbers on the sealed envelopes. The first group will be given 10 mg daily of Empagliflozine and the second group will be given 5 mg of Linagliptin daily for 90 days. It will be examined on microalbuminuria at the beginning and end of the study.

This study is a parallel randomized clinical trial. The study site will be Amir Al-Momenin Hospital in Arak and the duration of patient monitoring will be ninety days from the start of the drug recommendation. Blinding of patients by identifying drug packages and collector by separating checklist header information will be done.

Inclusion criteria: Age over 30 years old and under 75 years old Type 2 diabetes The patient has microalbuminuria Exclusion criteria: HbA1C> 9%. Uncontrolled hypertention Uncontrolled blood sugar Heart failure Chronic liver disease GFR lower than 30 Existence of hematuria Signs of active urinary tract and kidney infection Having a urinary catheter To be in nephropathy stages 3 or next stages Other kidney diseases that cause albuminuria such as glomerulonephritis Acute hospital conditions

This clinical trial was designed in two groups of 30 people. For one group, Empagliflozin 10 mg and for the other group 5 mg Linagliptin daily It will be given for 90 days.

The main outcome of the study on microalbuminuria, which is the main indicator of diabetic nephropathy, is evaluated by a random urine sample before treatment and at the end of the study period. Other Outcomes: Hba1c, FBS, GFR, and patients lipid profile.

Randomization method of this study is performed according to the random allocation rule, by first preparing a uniform and sealed envelope based on the total samples and an equal number of samples of each group, inside the envelopes on which the number one are written for the first intervention group and the number two are written for the second intervention group and patients randomly pick up an envelope when entering the study and allocate based on the numbers in the envelopes.

In this study, both the patient and the person entering the information into the checklist do not know what group the patient is in. The study is a double-blind study. Participants are blinded by identifying the shape of the drugs and similar packaging. To blind the data collector, the checklist header is removed so that it is not clear to which group the patient belongs.