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Trial record 1 of 1 for:    NCT01394341
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Liraglutide Treatment to Patients With Severe Renal Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01394341
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : October 9, 2013
Sponsor:
Collaborators:
Novo Nordisk A/S
The GCP unit at Copenhagen University Hospital
Information provided by (Responsible Party):
Bo Feldt-Rasmussen, Rigshospitalet, Denmark

Study Description
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Brief Summary:
Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is new and fundamentally different from the classical treatments with oral antidiabetic agents and insulin. The novel and original aspect of this investigator-initiated study is the focus on treatment with an incretin-based agent (the GLP-1 analogue liraglutide) in T2D patients with severely reduced kidney function. At present there is virtually no knowledge of the physiology and clinical implications of the role of incretin hormones and incretin-based therapy in this group of diabetic patients.The aim of the study is to establish an evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of antidiabetic drugs for patients with type T2D and severe renal insufficiency. The overall hypothesis is that patients with T2D and severe renal insufficiency will tolerate and benefit from treatment with the GLP-1 analogue liraglutide, hereby improving glycaemic control and reducing risk factors of cardiovascular disease

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus End-stage Renal Disease Drug: Liraglutide Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Effect of Liraglutide in Patients With Type 2 Diabetes and Severe Renal Insufficiency
Study Start Date : September 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: T2D, Dialysis, Liraglutide
Daily liraglutide treatment Chronic dialysis treatment
 Drug: Liraglutide
Daily sc. injection, individual dosage
Other Name: Victoza
Placebo Comparator: T2D, Dialysis, Placebo
Daily placebo Chronic dialysis treatment
 Drug: Liraglutide
Daily sc. injection, individual dosage
Other Name: Victoza
Active Comparator: T2D, Normal kidney function, Liraglutide
Daily Liraglutide treatment Normal kidney function
 Drug: Liraglutide
Daily sc. injection, individual dosage
Other Name: Victoza
Placebo Comparator: T2D, Normal kidney function, Placebo
Daily placebo treatment Normal kidney function
 Drug: Liraglutide
Daily sc. injection, individual dosage
Other Name: Victoza


Outcome Measures
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Primary Outcome Measures :
  1. Plasma liraglutide concentration (pmol/L) [ Time Frame: 12 weeks ]
    Plasma liraglutide concentration evaluated over time during continuous intervention


Secondary Outcome Measures :
  1. Hypoglycaemia; minor or major [ Time Frame: 12 weeks ]
    Number of hypoglycaemic episodes during intervention. Minor (blood glucose <3.1 mmol/L, no need for assistance). Major (blood glucose <3.1 mmol/L, assistance from third person required)

  2. Glycaemic control [ Time Frame: 12 weeka ]
    Glycaemic control evaluated from 3 daily measurements of blood glucose, from 4 periods of 24-hour tissue glucose measurements (5 days each) and from HbA1c during the intervention period.

  3. Pancreatic beta-cell function [ Time Frame: 12 weeks ]
    Pancreatic beta-cell function evaluated from insulin- and C-peptide-secretion during a standard meal test 3 times during the intervention period.

  4. Cardiovascular risk factors (lipids and blood pressure) [ Time Frame: 12 weeks ]
    Blood pressure will be evaluated at each visit and lipid profile (HDL, LDL, total cholesterol and triglyceride) 3 times during the intervention period.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria - patients with T2D in dialysis

  • Male or female; aged 18-85 years
  • 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)

Inclusion criteria - patients with T2D and normal kidney function

  • 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 - both groups

  • Type 1 diabetes mellitus
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394341


Locations
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Denmark
Department of Endocrinology PE, Copenhagen University Hospital, Rigshospitalet
Copenhagen Ø, Copenhagen, Denmark, 2100
Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
Copenhagen Ø, Copenhagen, Denmark, 2100
Department of Internal Medicine H, Hillerød Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Bo Feldt-Rasmussen
Novo Nordisk A/S
The GCP unit at Copenhagen University Hospital
Investigators
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Study Director: Bo Feldt-Rasmussen, Prof, DMSc Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
Principal Investigator: Thomas Idorn, MD Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bo Feldt-Rasmussen, Professor, DMSc, Head of Department, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01394341    
Other Study ID Numbers: H-3-2011-032
2010-021922-36 ( EudraCT Number )
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013
Keywords provided by Bo Feldt-Rasmussen, Rigshospitalet, Denmark:
Liraglutide
Uremia
Dialysis
 Type 2 diabetes mellitus
Safety
Efficacy
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency, Chronic
Chronic Disease
Disease Attributes
Pathologic Processes
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists