Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: Liraglutide; Drug: Placebo-liraglutide	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	11 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients
Study Start Date :	December 2012
Actual Primary Completion Date :	February 2014
Actual Study Completion Date :	February 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Liraglutide; 1.2 mg liraglutide sc. (single-dose)	Drug: Liraglutide; Other Name: Victoza
Placebo Comparator: Placebo-liraglutide; Placebo liraglutide sc. (single-dose)	Drug: Placebo-liraglutide; Other Name: Isotonic saline

Outcome Measures

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Primary Outcome Measures :

1. Glomerular Filtration Rate (51Cr-EDTA plasma clearance) [ Time Frame: 10-15 hours post-dose ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 60 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Denmark
Aarhus University Hospital, Department of Endocrinology and Diabetes
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Novo Nordisk A/S

University of Copenhagen

Investigators

Principal Investigator:	Jens S Christiansen, Professor	Aarhus University Hospital, Department of Endocrinology and Diabetes

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01664676 History of Changes
Other Study ID Numbers:	U1111-1131-5236; 2012-003577-26 ( EudraCT Number )
First Posted:	August 14, 2012
Last Update Posted:	February 28, 2014
Last Verified:	February 2014

Keywords provided by University of Aarhus:

liraglutide; victoza; GLP-1; kidney	diabetes; renal; diabetic nephropathy

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Liraglutide	Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists