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Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

This study is currently recruiting participants.
Verified January 2013 by University of Aarhus
Sponsor:
Collaborators:
Novo Nordisk
University of Copenhagen
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01664676
First received: August 10, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes

August 10, 2012
January 25, 2013
December 2012
January 2014   (final data collection date for primary outcome measure)
Glomerular Filtration Rate (51Cr-EDTA plasma clearance) [ Time Frame: 10-15 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01664676 on ClinicalTrials.gov Archive Site
  • 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 actice 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.
Same as current
Not Provided
Not Provided
 
Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients
A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Liraglutide
    Other Name: Victoza
  • Drug: Placebo-liraglutide
    Other Name: Isotonic saline
  • Experimental: Liraglutide
    1.2 mg liraglutide sc. (single-dose)
    Intervention: Drug: Liraglutide
  • Placebo Comparator: Placebo-liraglutide
    Placebo liraglutide sc. (single-dose)
    Intervention: Drug: Placebo-liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
March 2014
January 2014   (final data collection date for primary outcome measure)

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

Group specific inclusion criteria:

  • Normoalbuminuria (albumin/creatinine ratio < 2.5 mg/mmol) (n=12)
  • Microalbuminuria (albumin/creatinine ratio (10 to 25 mg/mmol)) (n=12)

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 < 90ml/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
Male
20 Years to 60 Years
No
Contact: Jeppe Skov, MD 78462071 ext +45 jsk@dadlnet.dk
Denmark
 
NCT01664676
U1111-1131-5236, 2012-003577-26
Yes
University of Aarhus
University of Aarhus
  • Novo Nordisk
  • University of Copenhagen
Principal Investigator: Jens S Christiansen, Professor Aarhus University Hospital, Department of Endocrinology and Diabetes
University of Aarhus
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP