Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients - Full Text View

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:

Drug Information available for: Liraglutide

U.S. FDA Resources

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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Glucagon-Like Peptide 1 Liraglutide	Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hypoglycemic Agents Incretins Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 01, 2015