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NCT Number: NCT01847313

The Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Diabetic Kidney Disease

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.

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Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St Vincent's Healthcare Group

Dublin, Dublin 4, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Daily administration of liraglutide for 6 months

Other names: Glucagon like peptide 1 receptor agonist, NN2211

Primary outcomes

  1. MCP-1:Creatinine Ratio in Urine

    Time frame: Up to 26 weeks

    Spot urine sample for MCP-1 and creatinine

Secondary outcomes

  1. Urine Albumin:Creatinine Ratio

    Time frame: Up to 26 weeks

    Spot urine sample for albumin and creatinine

  2. Urinary Albumin Excretion Rate

    Time frame: Up to 26 weeks

    Albuminuria as Measured by 24 Hour Albumin Excretion Rate

  3. sCD163 in Serum

    Time frame: Up to 26 weeks

    Serum sample for sCD163

  4. sCD163:Creatinine Ratio in Urine

    Time frame: Up to 26 weeks

    Spot urine sample for MCP-1 and creatinine

Other outcomes

  1. Safety in All Participants as Measured by Adverse Event Rate

    Time frame: Up to 34 weeks

    Adverse event data collection

Sponsors and collaborators

Lead sponsor

Karl Neff

Other

Collaborators

  • University College Dublin

Registry information

Official study title

Phase 3 Study of the Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Renal Outcomes in Humans With Diabetic Kidney Disease

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 6, 2013
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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