NCT01472640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

3.8 years

First QC Date

November 11, 2011

Last Update Submit

October 9, 2015

Conditions

HyperglycemiaChronic Heart Failure

Keywords

CHF, Diabetes; Liraglutid, Ecco

Outcome Measures

Primary Outcomes (1)

  • Change in Left ventricular function from visit 1 to week 24, measured by Ecco

    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.

    24 weeks

Secondary Outcomes (1)

  • left ventricular diastolic function

    24 weeks

Study Arms (2)

Liraglutid

ACTIVE COMPARATOR

Liraglutid

Drug: liraglutide

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

liraglutideDRUG

1.8 mg sc QOD

Also known as: Victoza
Liraglutid
placeboDRUG

1 U sc QOD

Placebo

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Skejby University Hospital

Aarhus, 8200, Denmark

Location

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Herlev University Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

  • Nielsen R, Jorsal A, Iversen P, Tolbod LP, Bouchelouche K, Sorensen J, Harms HJ, Flyvbjerg A, Tarnow L, Kistorp C, Gustafsson I, Botker HE, Wiggers H. Effect of liraglutide on myocardial glucose uptake and blood flow in stable chronic heart failure patients: A double-blind, randomized, placebo-controlled LIVE sub-study. J Nucl Cardiol. 2019 Apr;26(2):585-597. doi: 10.1007/s12350-017-1000-2. Epub 2017 Aug 2.

    PMID: 28770459DERIVED

  • Jorsal A, Wiggers H, Holmager P, Nilsson B, Nielsen R, Boesgaard TW, Kumme A, Moller JE, Videbaek L, Kistorp C, Gustafsson I, Tarnow L, Flyvbjerg A. A protocol for 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). BMJ Open. 2014 May 20;4(5):e004885. doi: 10.1136/bmjopen-2014-004885.

    PMID: 24844271DERIVED

MeSH Terms

Conditions

HyperglycemiaHeart FailureDiabetes Mellitus

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesCardiovascular DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Allan Flyvbjerg, dean

    University of Aarhus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2011

First Posted

November 16, 2011

Study Start

November 1, 2011

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

DK(4)