Status:
COMPLETED
The Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Diabetic Kidney Disease
Lead Sponsor:
Karl Neff
Collaborating Sponsors:
University College Dublin
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
Brief Summary
Diabetic kidney disease (DKD) is a devastating complication of diabetes, that in it's worst form, can lead to early cardiovascular death or kidney failure. A group of medicines used to treat diabetes,...
Detailed Description
A randomised controlled trial for patients with microalbuminuria and type 2 diabetes. Treatment is 0.6mg of liraglutide and is compared to standard care. Treatment duration is 6 months.
Eligibility Criteria
Inclusion
- Type 2 diabetes with a HbA1c of 42-75mmol/mol (6-9%DCCT)
- Male or female aged above 30 years
- Have a negative pregnancy test at screening (women of child bearing potential only)
- Body mass index (BMI) of 25kg/m2 or greater
- On a renin-angiotensin system antagonist, at a stable dose, for at least 8 weeks before inclusion into the study
- Established microalbuminuria
- Estimated glomerular filtration rate (eGFR) 30ml/min/1.73m2 or above by Modification of Diet in Renal Disease (MDRD) formula
Exclusion
- Patients with any cognitive impediment that preclude the patient from giving free and informed consent
- Patients on dipeptidyl peptidase 4 inhibitors or thiazolidinedione treatment
- Patients with stage 4-5 renal disease, defined as an eGFR of 30ml/min/1.73m2 or less
- Patients who have used a GLP-1 agent in the last 6 months
- 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
- Previous pancreatitis
- Hypersensitivity to GLP-1 analogues
- Proliferative diabetic retinopathy
- Any other contraindications, as per the SmPC for liraglutide
- 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
- Concurrent treatment with an investigational drug or participation in another clinical trial
- Use of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational medicinal product
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01847313
Start Date
April 1 2013
End Date
November 1 2015
Last Update
February 8 2019
Active Locations (1)
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1
St Vincent's Healthcare Group
Dublin, Ireland, Dublin 4