Clinical trial NCT01664676: Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients
Official title: A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: liraglutide
victoza
GLP-1
kidney
diabetes
renal
diabetic nephropathy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: University of Copenhagen
First posted: 2012-08-14
Enrollment: 11
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Glomerular Filtration Rate (51Cr-EDTA plasma clearance)
timeFrame: 10-15 hours post-dose
Secondary outcomes:
measure: Renal Blood Flow (functional magnetic resonance imaging)
timeFrame: 15 hours post-dose
measure: Renal electrolyte clearance
timeFrame: 10-15 hours post-dose
measure: Excretion of kidney injury markers
timeFrame: 0-10 hours and 10-15 hours post-dose
measure: Plasma concentrations of various hormones
timeFrame: 10-15 hours post-dose
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Endocrinology and Diabetes
Study officials:
affiliation: Aarhus University Hospital, Department of Endocrinology and Diabetes
name: Jens S Christiansen, Professor
role: PRINCIPAL_INVESTIGATOR
References: