The Effect of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes Mellitus

This study has been completed.
Novo Nordisk A/S
Information provided by (Responsible Party):
Flyvbjerg, Allan, DMSc Identifier:
First received: November 11, 2011
Last updated: October 9, 2015
Last verified: October 2015

Type 2 diabetes (T2D) is a major risk factor of chronic heart failure (CHF). Glycemic control in patients with the combination of T2D and CHF is complicated and the currently available treatments have proven to be inadequate in clinical trials.

Objectives To investigate the effect of Liraglutide compared to placebo on left ventricular ejection fraction (LVEF) in CHF patients with and without T2D.

Multicenter, randomized, double blind study of 240 patients with documented systolic CHF (50% with T2DM) will be randomised. The effect of Liraglutide on left ventricular systolic and diastolic function will be evaluated by advanced echocardiography

Primary outcome parameter is change in LVEF from visit 1 to week 24.

Condition Intervention
Chronic Heart Failure
Drug: liraglutide
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study of the Effect of LIraglutide on Left VEntricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes (The LIVE-study)

Resource links provided by NLM:

Further study details as provided by Flyvbjerg, Allan, DMSc:

Primary Outcome Measures:
  • Change in Left ventricular function from visit 1 to week 24, measured by Ecco [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Primary objective: To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo on left ventricular function in Chronic heart faillure patients with and without type 2 diabetes after 24 weeks of treatment.

Secondary Outcome Measures:
  • left ventricular diastolic function [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Secondary objectives: To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo on left ventricular diastolic function, on plasma levels of NT-proBNP, on symptoms of heart failure and quality of life over 24 weeks of treatment.

Enrollment: 240
Study Start Date: November 2011
Study Completion Date: October 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liraglutid
Drug: liraglutide
1.8 mg sc QOD
Other Name: Victoza
Placebo Comparator: Placebo
Drug: placebo
1 U sc QOD

  Show Detailed Description


Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Able to understand the written patient information and to give informed consent
  • CHF, NYHA-class I, II or III at visit 0
  • LVEF ≤45 %
  • Age 30 to 85 (both inclusive)
  • Stable pharmacological treatment of heart failure according to ESC guidelines for the last 3 months prior to randomisation (visit 1)

For patients with diabetes exclusively:

  • T2D (WHO criteria), diagnosed at least 3 months prior to visit 0
  • Patients with diabetes must be either untreated or treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs
  • Stable and optimal dose of anti diabetic treatment for 30 days prior to randomisation (visit 1)

Exclusion Criteria:

  • Myocardial infarction (MI), unstable angina or coronary revascularization within the last three months prior to visit 1
  • Hospitalisation due to incompensated heart disease within 30 days prior to randomisation (visit 1)
  • CHF (NYHA class IV)
  • ECG suggestive of malign ventricular arrhythmia at visit 0
  • Type 1 diabetes
  • HbA1c > 10% measured at visit 0
  • Use of GLP-1 receptor agonists (Exenatide, Liraglutide or other) or glitazones, pramlintide or any DPP-IV inhibitor within 30 days prior to randomisation (visit 1)
  • Known or suspected hypersensitivity to trial product or related products
  • Alcohol/drug abuse
  • Pregnant or nursing women
  • Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
  • Cancer unless in complete remission for ≥5 years
  • Liver disease with elevated plasma alanine aminotransferase (ALT) of more than three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
  • Inflammatory bowel disease
  • Acute or chronic pancreatitis
  • Gastroparesis
  • Compromised kidney function (eGFR < 30 ml/min), dialysis or kidney transplantation
  • History of thyroidea adenoma or carcinoma
  • Severely elevated blood pressure (systolic >180 mmHg and/or diastolic >105 mmHg)
  • Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
  • Simultaneous participation in any other clinical intervention trial
  • Receipt of an investigational drug with 30 days prior to visit 0
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01472640

Skejby University Hospital
Aarhus, Denmark, 8200
Steno Diabetes Center
Gentofte, Denmark, 2820
Herlev University Hospital
Herlev, Denmark, 2730
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Flyvbjerg, Allan, DMSc
Novo Nordisk A/S
Study Chair: Allan Flyvbjerg, dean University of Aarhus
  More Information

No publications provided

Responsible Party: Flyvbjerg, Allan, DMSc Identifier: NCT01472640     History of Changes
Other Study ID Numbers: DKprotokol(LIVE)v5, 2011-002468-26
Study First Received: November 11, 2011
Last Updated: October 9, 2015
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Flyvbjerg, Allan, DMSc:
CHF, Diabetes; Liraglutid, Ecco

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 27, 2015