ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01664676
Recruitment Status : Completed
First Posted : August 14, 2012
Last Update Posted : February 28, 2014
Sponsor:
Collaborators:
Novo Nordisk A/S
University of Copenhagen
Information provided by (Responsible Party):
University of Aarhus

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Liraglutide Drug: Placebo-liraglutide Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : December 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Glomerular Filtration Rate (51Cr-EDTA plasma clearance) [ Time Frame: 10-15 hours post-dose ]

Secondary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01664676     History of Changes
Other Study ID Numbers: U1111-1131-5236
2012-003577-26 ( EudraCT Number )
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014

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
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists