EUCTR2012-003577-26-DKActive, not recruitingPhase 1
iraglutide Kidney:A randomised, double-blinded, cross-over study investigating the short-term impact of liraglutide on kidney function in diabetic patients
Aarhus University Hospital0 sitesStarted: September 26, 2012Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 (estimated from creatinine concentration)
- •Impaired liver function: liver parameters exceed 2 times or more the upper normal limit, according to the hospital lab
- •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
Investigators
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