Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01664676
• Other study ID #: U1111-1131-5236
• Secondary ID: 2012-003577-26
• Status: Completed
• Phase: Phase 4
• First received: August 10, 2012
• Last updated: February 27, 2014
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Liraglutide

• Placebo-liraglutide

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Endocrinology and Diabetes	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Novo Nordisk A/S, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular Filtration Rate (51Cr-EDTA plasma clearance)		10-15 hours post-dose	No
Secondary	Renal Blood Flow (functional magnetic resonance imaging)		15 hours post-dose	No
Secondary	Renal electrolyte clearance	Sodium, potassium, calcium, lithium and osmotically active substances.	10-15 hours post-dose	No
Secondary	Excretion of kidney injury markers	Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.	0-10 hours and 10-15 hours post-dose	No
Secondary	Plasma concentrations of various hormones	Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.	10-15 hours post-dose	No