A study to evaluate the effect of a licensed drug to lower blood glucose, liraglutide, on inflammation in patients with diabetic kidney disease.

Phase 1

• Conditions: Diabetic Kidney Disease; MedDRA version: 18.0Level: LLTClassification code 10012687Term: Diabetic renal diseaseSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-005482-12-IE
• Lead Sponsor: niversity College Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-10
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified