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Phase 3 Study of the Effect of Glucagon-like-peptide 1 (GLP-1) Analogues on Inflammation in Humans With Diabetic Kidney Disease

Phase 3
30 Years
70 Years
Open (Enrolling)
Diabetic Kidney Disease

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Trial Information

Phase 3 Study of the Effect of Glucagon-like-peptide 1 (GLP-1) Analogues on Inflammation in Humans With Diabetic Kidney Disease

Inclusion Criteria:

- Type 2 diabetes with a HbA1c of 42-64mmol/mol (6-8%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 metformin treatment, at a stable dose, for at least 12 weeks before inclusion into
the study, with or without sulphonylurea treatment

- 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) 31 to 59 ml/min/1.73m2 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 on insulin therapy

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Monocyte-chemoattractant protein 1 (MCP-1) in urine

Outcome Time Frame:

Up to 26 weeks

Safety Issue:



Ireland: Irish Medicines Board

Study ID:




Start Date:

April 2013

Completion Date:

Related Keywords:

  • Diabetic Kidney Disease
  • Diabetic Nephropathies
  • Inflammation
  • Kidney Diseases