Liraglutide Treatment to Patients With Severe Renal Insufficiency
NCT ID: NCT01394341
Last Updated: 2013-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2011-09-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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T2D, Dialysis, Liraglutide
Daily liraglutide treatment Chronic dialysis treatment
Liraglutide
Daily sc. injection, individual dosage
T2D, Dialysis, Placebo
Daily placebo Chronic dialysis treatment
Liraglutide
Daily sc. injection, individual dosage
T2D, Normal kidney function, Liraglutide
Daily Liraglutide treatment Normal kidney function
Liraglutide
Daily sc. injection, individual dosage
T2D, Normal kidney function, Placebo
Daily placebo treatment Normal kidney function
Liraglutide
Daily sc. injection, individual dosage
Interventions
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Liraglutide
Daily sc. injection, individual dosage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* End-stage renal disease
* Chronic dialysis treatment (minimum 3 months)
* T2D (diagnosed according to WHO criteria)
* Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin
* Documented beta cell function (evaluated by a glucagon test)
* Male or female; aged 18-85 years
* Normal kidney function: Plasma creatinine \<0.105 mmol/L for men and \<0.090 mmol/L for women
* T2D (diagnosed according to WHO criteria)
* Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin
* Documented beta cell function (evaluated by a glucagon test)
* Hemoglobin A1c ≥6.5%
Exclusion Criteria
* Chronic pancreatitis / previous acute pancreatitis
* Known or suspected hypersensitivity to trial product(s) or related products
* Treatment with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors or other drugs, which in the Investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening
* Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder which in the investigators' opinion could interfere with the results of the trial
* Inflammatory bowel disease
* Cardiac disease defined as: decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
* Body mass index ≤ 18.5 kg/m2 or ≥ 50.0 kg/m2
* Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
* Clinical signs of diabetic gastroparesis
* Impaired liver function (transaminases \>two times upper reference levels)
* Receipt of any investigational product 90 days prior to this trial
* Known or suspected abuse of alcohol or narcotics
* Screening calcitonin ≥50 ng/l
* Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
18 Years
85 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
The GCP unit at Copenhagen University Hospital
UNKNOWN
Bo Feldt-Rasmussen
OTHER
Responsible Party
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Bo Feldt-Rasmussen
Professor, DMSc, Head of Department
Principal Investigators
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Bo Feldt-Rasmussen, Prof, DMSc
Role: STUDY_DIRECTOR
Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
Thomas Idorn, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
Locations
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Department of Endocrinology PE, Copenhagen University Hospital, Rigshospitalet
Copenhagen Ø, Copenhagen, Denmark
Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
Copenhagen Ø, Copenhagen, Denmark
Department of Internal Medicine H, Hillerød Hospital
Hillerød, , Denmark
Countries
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References
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Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Idorn T, Knop FK, Jorgensen MB, Jensen T, Resuli M, Hansen PM, Christensen KB, Holst JJ, Hornum M, Feldt-Rasmussen B. Safety and Efficacy of Liraglutide in Patients With Type 2 Diabetes and End-Stage Renal Disease: An Investigator-Initiated, Placebo-Controlled, Double-Blind, Parallel-Group, Randomized Trial. Diabetes Care. 2016 Feb;39(2):206-13. doi: 10.2337/dc15-1025. Epub 2015 Aug 17.
Idorn T, Knop FK, Jorgensen M, Jensen T, Resuli M, Hansen PM, Christensen KB, Holst JJ, Hornum M, Feldt-Rasmussen B. Safety and efficacy of liraglutide in patients with type 2 diabetes and end-stage renal disease: protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded, parallel intervention study. BMJ Open. 2013 Apr 26;3(4):e002764. doi: 10.1136/bmjopen-2013-002764. Print 2013.
Other Identifiers
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2010-021922-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H-3-2011-032
Identifier Type: -
Identifier Source: org_study_id