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July 1, 2014BMJ OpenOpen Access

Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes (the AddHope2 study): a randomised controlled study protocol

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Key result

This randomized controlled study protocol outlines a cross-over trial to evaluate the effect of liraglutide added to metformin on left ventricular ejection fraction in 40 patients with CAD and T2DM.

Why the study?

Does liraglutide added to metformin improve left ventricular ejection fraction during stress echocardiography and β-cell function in patients with CAD and newly diagnosed T2DM?

Population

40 patients with coronary artery disease (CAD) and newly diagnosed type-2 diabetes mellitus (T2DM)

Comparison

Liraglutide added to metformin backbone therapy vs Placebo added to metformin backbone therapy

Design

Other, randomised, double blind, placebo-controlled

Follow-up

12 plus 12 weeks cross-over with a 2-week washout period

Authors

CAChristian AnholmAmager HospitalPKPreman KumarathuraiUniversity of Southern DenmarkMKMalene S KlitBispebjerg Hospital

Discussion

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Overview

This study protocol describes a randomized cross-over trial to assess the effects of liraglutide on cardiac and beta-cell function in patients with CAD and newly diagnosed T2DM.

Study Design

Type

RCT (n=40)

Blinding

double blind

Randomization

cross-over

Structured PICO

Does liraglutide added to metformin improve left ventricular ejection fraction during stress echocardiography and β-cell function in patients with CAD and newly diagnosed T2DM?

P
Population
40 patients with coronary artery disease and newly diagnosed type-2 diabetes enrolled in a 12-week cross-over trial.
I
Intervention
Liraglutide added to metformin backbone therapy
C
Comparator
Placebo added to metformin backbone therapy
O
Outcome
Changes in left ventricular ejection fraction during stress echocardiography (cardiovascular) and β-cell function evaluated during a frequently sampled intravenous glucose tolerance test (endocrine)surrogate

This study protocol describes a randomized cross-over trial to assess the effects of liraglutide on cardiac and beta-cell function in patients with CAD and newly diagnosed T2DM.

Cite This Study

Anholm et al. (2014) conducted an RCT in coronary artery disease and newly diagnosed type-2 diabetes (n=40). liraglutide + metformin vs. placebo + metformin was evaluated on changes in left ventricular ejection fraction during stress echocardiography and β-cell function. This randomized controlled study protocol outlines a cross-over trial to evaluate the effect of liraglutide added to metformin on left ventricular ejection fraction in 40 patients with CAD and T2DM.

synapsesocial.com/papers/6a9dd6abedb3f34bcaf42e3bhttps://doi.org/10.1136/bmjopen-2014-005942
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Also Consider

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