Liraglutide Treatment to Patients With Severe Renal Insufficiency

This study has been completed.
Sponsor:
Collaborators:
Novo Nordisk A/S
The GCP unit at Copenhagen University Hospital
Information provided by (Responsible Party):
Bo Feldt-Rasmussen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01394341
First received: July 11, 2011
Last updated: October 8, 2013
Last verified: October 2013

July 11, 2011
October 8, 2013
September 2011
October 2013   (final data collection date for primary outcome measure)
Plasma liraglutide concentration (pmol/L) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Plasma liraglutide concentration evaluated over time during continuous intervention
Same as current
Complete list of historical versions of study NCT01394341 on ClinicalTrials.gov Archive Site
  • Hypoglycaemia; minor or major [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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)
  • Glycaemic control [ Time Frame: 12 weeka ] [ Designated as safety issue: No ]
    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.
  • Pancreatic beta-cell function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Pancreatic beta-cell function evaluated from insulin- and C-peptide-secretion during a standard meal test 3 times during the intervention period.
  • Cardiovascular risk factors (lipids and blood pressure) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Blood pressure will be evaluated at each visit and lipid profile (HDL, LDL, total cholesterol and triglyceride) 3 times during the intervention period.
Same as current
Not Provided
Not Provided
 
Liraglutide Treatment to Patients With Severe Renal Insufficiency
Safety and Effect of Liraglutide in Patients With Type 2 Diabetes and Severe Renal Insufficiency

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • End-stage Renal Disease
Drug: Liraglutide
Daily sc. injection, individual dosage
Other Name: Victoza
  • Active Comparator: T2D, Dialysis, Liraglutide
    Daily liraglutide treatment Chronic dialysis treatment
    Intervention: Drug: Liraglutide
  • Placebo Comparator: T2D, Dialysis, Placebo
    Daily placebo Chronic dialysis treatment
    Intervention: Drug: Liraglutide
  • Active Comparator: T2D, Normal kidney function, Liraglutide
    Daily Liraglutide treatment Normal kidney function
    Intervention: Drug: Liraglutide
  • Placebo Comparator: T2D, Normal kidney function, Placebo
    Daily placebo treatment Normal kidney function
    Intervention: Drug: Liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01394341
H-3-2011-032, 2010-021922-36
Yes
Bo Feldt-Rasmussen, Rigshospitalet, Denmark
Bo Feldt-Rasmussen
  • Novo Nordisk A/S
  • The GCP unit at Copenhagen University Hospital
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
Rigshospitalet, Denmark
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP