NCT01472640

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)

Completed NA Last updated 9 October 2015

What this trial tests

NA trial testing liraglutide in Hyperglycemia in 240 participants. Completed in 1 October 2015.

Timeline

1 November 2011

Primary endpoint
1 September 2015

1 October 2015

Quick facts

Lead sponsor	Flyvbjerg, Allan, DMSc
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	240
Start date	1 November 2011
Primary completion	1 September 2015
Estimated completion	1 October 2015
Sites	4 locations across Denmark

Drugs / interventions tested

• liraglutide (liraglutide) — full drug profile →
• placebo

Conditions studied

• Hyperglycemia — all drugs for Hyperglycemia →
• Chronic Heart Failure — all drugs for Chronic Heart Failure →

Sponsor

Flyvbjerg, Allan, DMSc

Who can join

Adults 30 to 85, any sex, with Hyperglycemia or Chronic Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Nielsen R, Jorsal A, Iversen P, Tolbod LP, et al · · 2019 · cited 32× · PMID 28770459 · DOI 10.1007/s12350-017-1000-2
2. Dipeptidyl-peptidase (DPP)-4 inhibitors and glucagon-like peptide (GLP)-1 analogues for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk for the development of type 2 diabetes mellitus.
   Hemmingsen B, Sonne DP, Metzendorf MI, Richter B. · · 2017 · cited 31× · PMID 28489279 · DOI 10.1002/14651858.cd012204.pub2
3. 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).
   Jorsal A, Wiggers H, Holmager P, Nilsson B, et al · · 2014 · cited 20× · PMID 24844271 · DOI 10.1136/bmjopen-2014-004885
4. Abstracts of 52nd EASD Annual Meeting.
   · 2016 · cited 6× · PMID 27539147 · DOI 10.1007/s00125-016-4046-9
5. Heart Failure with Preserved Ejection Fraction: a Pharmacotherapeutic Update.
   Vaz-Salvador P, Adão R, Vasconcelos I, Leite-Moreira AF, et al · · 2023 · cited 5× · PMID 35098432 · DOI 10.1007/s10557-021-07306-8
6. Exogenous Ketones in Cardiovascular Disease and Diabetes: From Bench to Bedside.
   Kansakar U, Nieves Garcia C, Santulli G, Gambardella J, et al · · 2024 · cited 4× · PMID 39685849 · DOI 10.3390/jcm13237391
7. Diabetes and cardiovascular disease: focus on glucagon-like peptide-1 based therapies.
   Stranges P, Khanderia U. · · 2012 · cited 4× · PMID 25083236 · DOI 10.1177/2042098612454290
8. Evaluation of the therapeutic effect of new hypoglycemic drugs on patients with heart failure with reduced ejection fraction and type 2 diabetes: a systematic review and network meta-analysis.
   Chen XR, Mao XP, Luo D, Yu CQ, et al · · 2026 · PMID 42181653 · DOI 10.3389/fcvm.2026.1799254