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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2014