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:
University of Aarhus
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
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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:
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 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.
| Estimated Enrollment: | 24 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | January 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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664676
Contacts
| Contact: Jeppe Skov, MD | 78462071 ext +45 | jsk@dadlnet.dk |
Locations
| Denmark | |
| Aarhus University Hospital, Department of Endocrinology and Diabetes | Recruiting |
| Aarhus, Denmark, 8000 | |
| Contact: Jeppe Skov, MD 78462071 ext +45 jsk@dadlnet.dk | |
| Principal Investigator: Jeppe Skov, MD | |
Sponsors and Collaborators
University of Aarhus
Novo Nordisk
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: | January 25, 2013 |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glucagon-Like Peptide 1 |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013