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Completed

NCT Number: NCT01664676

Effects of Liraglutide on Kidney Function in Type 2 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital, Department of Endocrinology and Diabetes

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Other names: Victoza

Placebo-liraglutide

Drug

Other names: Isotonic saline

Primary outcomes

  1. Glomerular Filtration Rate (51Cr-EDTA plasma clearance)

    Time frame: 10-15 hours post-dose

Secondary outcomes

  1. Renal Blood Flow (functional magnetic resonance imaging)

    Time frame: 15 hours post-dose

  2. Renal electrolyte clearance

    Time frame: 10-15 hours post-dose

    Sodium, potassium, calcium, lithium and osmotically active substances.

  3. Excretion of kidney injury markers

    Time frame: 0-10 hours and 10-15 hours post-dose

    Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.

  4. Plasma concentrations of various hormones

    Time frame: 10-15 hours post-dose

    Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Novo Nordisk A/S
  • University of Copenhagen

Registry information

Official study title

A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 14, 2012
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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