Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Collaborators:
Novo Nordisk A/S
University of Copenhagen
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01664676
First received: August 10, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against diabetic nephropathy. We hypothesise that this is also the case in humans. This study will investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2 diabetic patients. Impact on basic kidney physiological will be determined and kidney injury markers will be measured as surrogate parameters of kidney protection.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Liraglutide
Drug: Placebo-liraglutide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Glomerular Filtration Rate (51Cr-EDTA plasma clearance) [ Time Frame: 10-15 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal Blood Flow (functional magnetic resonance imaging) [ Time Frame: 15 hours post-dose ] [ Designated as safety issue: No ]
  • Renal electrolyte clearance [ Time Frame: 10-15 hours post-dose ] [ Designated as safety issue: No ]
    Sodium, potassium, calcium, lithium and osmotically active substances.

  • Excretion of kidney injury markers [ Time Frame: 0-10 hours and 10-15 hours post-dose ] [ Designated as safety issue: No ]
    Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.

  • Plasma concentrations of various hormones [ Time Frame: 10-15 hours post-dose ] [ Designated as safety issue: No ]
    Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.


Enrollment: 11
Study Start Date: December 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide
1.2 mg liraglutide sc. (single-dose)
Drug: Liraglutide
Other Name: Victoza
Placebo Comparator: Placebo-liraglutide
Placebo liraglutide sc. (single-dose)
Drug: Placebo-liraglutide
Other Name: Isotonic saline

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities.
  • Male gender
  • T2DM, diagnosed according to international guidelines
  • Age 20-60 years, both included
  • Body Mass Index (BMI): 20-32 kg/m2, both included
  • Metformin treatment
  • Albumin/creatinine ratio <25 mg/mmol

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Previous participation in this trial
  • Previous treatment with GLP-1 analogues or DPP-4 inhibitors
  • Current treatment with any antidiabetic drug other than metformin
  • Poorly regulated glycemic control (HbA1c > 8%)
  • Impaired kidney function: estimated GFR < 70ml/min
  • Impaired liver function: liver parameters exceed 2 times upper normal limit
  • Subjects with active malignancy
  • Severe cardiac insufficiency classified according to NYHA III-IV
  • Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months
  • Severe, uncontrolled hypertension: sitting blood pressure (BP) > 180/110 mmHg
  • Antihypertensive treatment consisting of more than two different pharmaceutical products
  • Symptoms related to benign prostate hyperplasia
  • Claustrophobia
  • Any metal body implants
  • History of pancreatitis, type 1 diabetes, gastroparesis or multiple endocrine neoplasia syndrome type 2
  • Personal or family history of medullary thyroid carcinoma
  • Any diseases judged by the investigator that could affect the trial
  • Any medication judged by the investigator that could affect the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664676

Locations
Denmark
Aarhus University Hospital, Department of Endocrinology and Diabetes
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Novo Nordisk A/S
University of Copenhagen
Investigators
Principal Investigator: Jens S Christiansen, Professor Aarhus University Hospital, Department of Endocrinology and Diabetes
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01664676     History of Changes
Other Study ID Numbers: U1111-1131-5236, 2012-003577-26
Study First Received: August 10, 2012
Last Updated: February 27, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
liraglutide
victoza
GLP-1
kidney
diabetes
renal
diabetic nephropathy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014