Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Liraglutide; Drug: Placebo-liraglutide

• Registration Number: NCT01664676
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-14
• Study Start: 2012-12
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Liraglutide	Liraglutide	1.2 mg liraglutide sc. (single-dose)
Placebo-liraglutide	Placebo-liraglutide	Placebo liraglutide sc. (single-dose)

Primary Outcome Measures

Name	Time	Method
Glomerular Filtration Rate (51Cr-EDTA plasma clearance)	10-15 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Renal Blood Flow (functional magnetic resonance imaging)	15 hours post-dose
Renal electrolyte clearance	10-15 hours post-dose	Sodium, potassium, calcium, lithium and osmotically active substances.
Excretion of kidney injury markers	0-10 hours and 10-15 hours post-dose	Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.
Plasma concentrations of various hormones	10-15 hours post-dose	Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Endocrinology and Diabetes; 🇩🇰 Aarhus, Denmark