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

NCT ID: NCT01847313

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-11-30

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, 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.

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.

Conditions

Diabetic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liraglutide

Liraglutide 0.6 mg daily

Group Type: ACTIVE_COMPARATOR

Liraglutide

Intervention Type: DRUG

Daily administration of liraglutide for 6 months

Control

Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Liraglutide

Daily administration of liraglutide for 6 months

Intervention Type: DRUG

Other Intervention Names

Glucagon like peptide 1 receptor agonist; NN2211

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College Dublin

OTHER

Sponsor Role: collaborator

Karl Neff

OTHER

Sponsor Role: lead

Responsible Party

Karl Neff

Clinical Research Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carel le Roux, MBBS PhD

Role: STUDY_DIRECTOR

University College Dublin

Locations

St Vincent's Healthcare Group

Dublin, , Ireland

Countries

Ireland

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Other Identifiers

GLP-1-2012-01

Identifier Type: -

Identifier Source: org_study_id