Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Novo Nordisk A/S; University of Copenhagen
• Treatments: Liraglutide

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