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The effect of linagliptin on microalbuminuria in diabetes patients

The evaluation of the effect of linagliptin on microalbuminuria in type 2 diabetes patients with nephropathy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171030037093N11
Enrollment
80
Registered
2019-05-08
Start date
2019-05-20
Completion date
Unknown
Last updated
2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic nephropathy. Type 2 diabetes mellitus with diabetic nephropathy

Interventions

Intervention 1: Intervention group: A group treated with lagglyptin 5 mg for 24 weeks. Intervention 2: Control group: A group treated with placebo for 24 weeks.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Urine 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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAshraf Aminorroaya

Esfahan University of Medical Sciences

aminorroaya@med.mui.ac.ir+98 31 3220 5915

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026