Diabetic Kidney Disease MedDRA version: 18.0 Level: LLT Classification code 10012687 Term: Diabetic renal disease System Organ Class: 100000004857
Conditions
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only patients who meet all of the following inclusion criteria will be eligible for enrolment into this study: 1. Type 2 diabetes with a HbA1c of 42-75mmol/mol (6-9%DCCT) 2. Male or female between 30 – 75 years of age 3. Have a negative pregnancy test at screening (women of child bearing potential only) 4. Body mass index (BMI) of 25kg/m2or greater 5. On a renin-angiotensin system antagonist, at a stable dose, for at least 8 weeks before inclusion into the study 6. Established microalbuminuria (as defined by two positive urine test results) 7. Estimated glomerular filtration rate (eGFR) 30 ml/min/1.73m2 or greater by Modification of Diet in Renal Disease (MDRD) formula Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Patients meeting any of the following exclusion criteria are not eligible for enrolment into this study: 1. Patients with any cognitive impediment that preclude the patient from giving free and informed consent 2. Patients on dipeptidyl peptidase 4 inhibitors 3. Patients who require insulin therapy who are not using an insulin product with an indication for adding in liraglutide 4. Patients with stage 4-5 renal disease, defined as an eGFR of 29ml/min/1.73m2 or less 5. Patients who have used a GLP-1 agent in the last 6 months 6. Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception or abstinence during participation in the study 7. Previous pancreatitis 8. Hypersensitivity to GLP-1 analogues 9. Proliferative diabetic retinopathy 10. Any other contraindications, as per the SmPC for liraglutide 11. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements 12. Concurrent treatment with an investigational drug or participation in another clinical trial 13. Use of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational medicinal product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: The primary objective of this study is to compare the change in pro-inflammatory cytokine monocyte-chemotactic protein 1 (MCP-1) in urine in subjects treated with liraglutide over a 26 week treatment period versus a matched control group who received no liraglutide. ;Secondary Objective: The secondary objectives of this study are to compare: 1. Changes in serum and urine sCD163 2. Changes in urinary albumin excretion rates 3. Safety between both subject groups over a 26 week treatment period. ;Primary end point(s): The primary endpoint of this study is the measurement of the change in pro-inflammatory cytokine monocyte-chemotactic protein 1 (MCP-1) in urine over a 26 week treatment period in subjects treated with liraglutide versus a matched control group who received no liraglutide.;Timepoint(s) of evaluation of this end point: After a 26 week period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of this study are the measurement of: 1. Changes in serum and urine sCD163 2. Changes in urinary albumin excretion rates 3. Safety as measured by changes from Baseline Visit in physical examination findings, safety laboratory test results, vital signs and adverse events reported between both subject groups. ;Timepoint(s) of evaluation of this end point: After a 26 week period. | — |
Countries
Ireland
Contacts
Public ContactKarl Neff
UCD Clinical Research Centre, St Vincent's University Hospital
Outcome results
None listed