Liraglutide Treatment to Patients With Severe Renal Insufficiency

October 8, 2013 updated by: Bo Feldt-Rasmussen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hillerød, Denmark, 3400
        • Department of Internal Medicine H, Hillerød Hospital
    • Copenhagen
      • Copenhagen Ø, Copenhagen, Denmark, 2100
        • Department of Endocrinology PE, Copenhagen University Hospital, Rigshospitalet
      • Copenhagen Ø, Copenhagen, Denmark, 2100
        • Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: T2D, Dialysis, Liraglutide
Daily liraglutide treatment Chronic dialysis treatment
Drug: Liraglutide
Daily sc. injection, individual dosage
Other Names:
  • Victoza
Placebo Comparator: T2D, Dialysis, Placebo
Daily placebo Chronic dialysis treatment
Drug: Liraglutide
Daily sc. injection, individual dosage
Other Names:
  • Victoza
Active Comparator: T2D, Normal kidney function, Liraglutide
Daily Liraglutide treatment Normal kidney function
Drug: Liraglutide
Daily sc. injection, individual dosage
Other Names:
  • Victoza
Placebo Comparator: T2D, Normal kidney function, Placebo
Daily placebo treatment Normal kidney function
Drug: Liraglutide
Daily sc. injection, individual dosage
Other Names:
  • Victoza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma liraglutide concentration (pmol/L)
Time Frame: 12 weeks
Plasma liraglutide concentration evaluated over time during continuous intervention
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks
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.
12 weeka
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bo Feldt-Rasmussen

Collaborators

Novo Nordisk A/S
The GCP unit at Copenhagen University Hospital

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimate)

July 14, 2011

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2011-032
  • 2010-021922-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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