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

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. Identifier: NCT01472640
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : October 12, 2015
Novo Nordisk A/S
Information provided by (Responsible Party):
Flyvbjerg, Allan, DMSc

Brief Summary:

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 or disease Intervention/treatment Phase
Hyperglycemia Chronic Heart Failure Drug: liraglutide Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : November 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Liraglutid
Drug: liraglutide
1.8 mg sc QOD
Other Name: Victoza

Placebo Comparator: Placebo
Drug: placebo
1 U sc QOD

Primary Outcome Measures :
  1. Change in Left ventricular function from visit 1 to week 24, measured by Ecco [ Time Frame: 24 weeks ]
    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 :
  1. left ventricular diastolic function [ Time Frame: 24 weeks ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01472640

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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
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Study Chair: Allan Flyvbjerg, dean University of Aarhus
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Flyvbjerg, Allan, DMSc Identifier: NCT01472640    
Other Study ID Numbers: DKprotokol(LIVE)v5
2011-002468-26 ( EudraCT Number )
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Keywords provided by Flyvbjerg, Allan, DMSc:
CHF, Diabetes; Liraglutid, Ecco
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists