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

September 17, 2018 updated by: Karl Neff

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, Dublin 4
        • St Vincent's Healthcare Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Liraglutide
Liraglutide 0.6 mg daily
Drug: Liraglutide
Daily administration of liraglutide for 6 months
Other Names:
  • Glucagon like peptide 1 receptor agonist
  • NN2211
No Intervention: Control
Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MCP-1:Creatinine Ratio in Urine
Time Frame: Up to 26 weeks
Spot urine sample for MCP-1 and creatinine
Up to 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine Albumin:Creatinine Ratio
Time Frame: Up to 26 weeks
Spot urine sample for albumin and creatinine
Up to 26 weeks
Urinary Albumin Excretion Rate
Time Frame: Up to 26 weeks
Albuminuria as Measured by 24 Hour Albumin Excretion Rate
Up to 26 weeks
sCD163 in Serum
Time Frame: Up to 26 weeks
Serum sample for sCD163
Up to 26 weeks
sCD163:Creatinine Ratio in Urine
Time Frame: Up to 26 weeks
Spot urine sample for MCP-1 and creatinine
Up to 26 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety in All Participants as Measured by Adverse Event Rate
Time Frame: Up to 34 weeks
Adverse event data collection
Up to 34 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karl Neff

Collaborators

University College Dublin

Investigators

  • Study Director: Carel le Roux, MBBS PhD, University College Dublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (Estimate)

May 6, 2013

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLP-1-2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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