The effect of linagliptin on microalbuminuria in diabetes patients

Phase 3

Recruiting

• Conditions: Diabetic nephropathy.; Type 2 diabetes mellitus with diabetic nephropathy; E11.21

• Registration Number: IRCT20171030037093N11
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 21 May 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients with 6.5% to 10% glycated hemoglobin (hemoglobin HbA1c) (48 to 86 mmol / mol)
Patients with BMI = 40 kg / m²
The level of albumin to creatinine (UACR) ranged from 30 to 3000 mg / g creatinine (in three urine samples consecutive two weeks before the start of the study)

Exclusion Criteria

Patients who consumed rapid acting insulin, rosiglitazone, pioglitazone, GLP-1 analogues, or anti-obesity drugs three months before the start of the study
Patients who had myocardial infarction, stroke, or transient ischemic attack six months before the start of the study.
Patients with non-diabetic renal insufficiency or urinary tract infection
Patients who have received kidney transplants

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rine Albumin-to-Creatinine Ratio. Timepoint: In three urine samples collected consecutively two weeks before the start of the study and two weeks after the start of the study and then every 4 weeks. Method of measurement: Experiments.;Blood pressure. Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: measurement.

Secondary Outcome Measures

Name	Time	Method
Body mass index. Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: measurement.;Level glycosylated hemoglobin. Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: Experiments.;Glomerular filtration rate (GFR). Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: MDRD formula.;Liver Enzymes (ALT? AST? ALP). Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: Experiments.;Profile Lipid (TG? LDL? HDL? total cholesterol). Timepoint: At the beginning of the study, 12 and 24 weeks after the start of the intervention. Method of measurement: Experiments.