Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients
February 27, 2014 updated by: University of Aarhus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Aarhus, Denmark, 8000
- Aarhus University Hospital, Department of Endocrinology and Diabetes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Liraglutide
1.2 mg liraglutide sc.
(single-dose)
|
Other Names:
|
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Placebo Comparator: Placebo-liraglutide
Placebo liraglutide sc.
(single-dose)
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glomerular Filtration Rate (51Cr-EDTA plasma clearance)
Time Frame: 10-15 hours post-dose
|
10-15 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Renal Blood Flow (functional magnetic resonance imaging)
Time Frame: 15 hours post-dose
|
15 hours post-dose
|
|
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Renal electrolyte clearance
Time Frame: 10-15 hours post-dose
|
Sodium, potassium, calcium, lithium and osmotically active substances.
|
10-15 hours post-dose
|
|
Excretion of kidney injury markers
Time Frame: 0-10 hours and 10-15 hours post-dose
|
Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.
|
0-10 hours and 10-15 hours post-dose
|
|
Plasma concentrations of various hormones
Time Frame: 10-15 hours post-dose
|
Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.
|
10-15 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jens S Christiansen, Professor, Aarhus University Hospital, Department of Endocrinology and Diabetes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
August 10, 2012
First Submitted That Met QC Criteria
August 10, 2012
First Posted (Estimate)
August 14, 2012
Study Record Updates
Last Update Posted (Estimate)
February 28, 2014
Last Update Submitted That Met QC Criteria
February 27, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1131-5236
- 2012-003577-26 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.