The Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: Liraglutide
Intervention description: Daily administration of liraglutide for 6 months
Intervention MeSH terms: Liraglutide; Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: kidney; diabetes; glp-1

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, glucagon-like-peptide-1 analogues (GLP-1), may be able to protect people with
      diabetes from DKD by reducing inflammation in the kidney. This study aims to test this theory
      by studying the effect of GLP-1 on kidney function in people with diabetes.

      To understand how GLP-1 can affect inflammation, the investigators will give a GLP-1
      treatment (Liraglutide) to people with DKD and monitor the effect on inflammation and kidney
      function using blood and urine tests. The investigators will compare these results to
      patients with DKD who do not receive GLP-1 treatment.

      If GLP-1 proves to be effective in reducing inflammation and improving kidney function, then
      it could be developed as a viable new treatment for people with DKD, and may significantly
      reduce the disease burden, or the risk of DKD, in people with diabetes. This would be a major
      advance in the treatment of DKD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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