A new therapeutic approach to prevent acute complications in type 2 diabetes: The effect of the combination of the GLP-1 Analog Liraglutide and Insulin LEvemir® against the cOnventional insulin therapy: GALILEO

A new therapeutic approach to prevent acute insulin-mediated complications in type 2 diabetes Subtitle: The effect of the combination of the GLP-1 Analog Liraglutide and Insulin LEvemir® vs. cOnventional insulin therapy: GALILEO - GALILEO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001208-39-AT

Enrollment

Registered

2012-04-17

Start date

2012-05-14

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus type 2, inadequate metabolic control, indication for insulin therapy myocardial lipid accumulation and left-ventricular function, retinal changes, microabluminuria, beta-cell-function, endothelial dysfunction MedDRA version: 14.1 Level: PT Classification code 10012607 Term: Diabetes mellitus inadequate control System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: PT Classification code 10012689 Term: Diabetic retinopathy System Organ Cl

Interventions

Product Name: Insulin Levemir Product Code: EMEA/H/C/000528 Pharmaceutical Form: Injection INN or Proposed INN: INSULIN DETEMIR CAS Number: 169148-63-4 Concentration unit: IU/ml international unit(s)/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Type 2 diabetes • Currently under oral glucose lowering medication • Insufficient metabolic control: HbA1C > 8% • Patient understands study procedure and gives written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Age < 18 years • Type 1 Diabetes, LADA-Diabetes • Prior insulin administration/therapy • Therapy with thiazolidiones • Known cardiovascular disease (history of myocardial infarction, stroke etc) • Severe arterial hypertension • Acute or chronic inflammatory disease within 2 weeks prior the study • Kidney or liver disease • Psychiatric disorder • Tendency towards claustrophobia • metal devices or other magnetic material in or on the subjects body which will be hazardous for NMR investigation

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the current study is to evaluate the acute effects of gradual, insulin sparing (GLP-1-based therapy) versus acute (insulin-based therapy) glucose lowering on myocardial lipid content (assessed by MR-spectroscopy) in patients with type 2 diabetes.;Secondary Objective: Changes in •hepato-cellular lipid content •left ventricular function (ejection fraction, end-systolic volume, end-diastolic volume, stroke volume, cardiac output, mass, wall thickness, E/A-ratio) and remodeling-indices •retinal morphology, perfusion and function as measured by Optical Coherence Tomography (SD-OCT) and fluorescein angiography •retinal function measured by microperimetry •biomarkers of endothelial dysfunction •microalbuminuria •beta-cell-function ;Primary end point(s): Changes in myocardial lipid content (assessed by MR-spectroscopy) ;Timepoint(s) of evaluation of this end point: study day 28	—

Measure

Time frame

Main Objective: The aim of the current study is to evaluate the acute effects of gradual, insulin sparing (GLP-1-based therapy) versus acute (insulin-based therapy) glucose lowering on myocardial lipid content (assessed by MR-spectroscopy) in patients with type 2 diabetes.;Secondary Objective: Changes in •hepato-cellular lipid content •left ventricular function (ejection fraction, end-systolic volume, end-diastolic volume, stroke volume, cardiac output, mass, wall thickness, E/A-ratio) and remodeling-indices •retinal morphology, perfusion and function as measured by Optical Coherence Tomography (SD-OCT) and fluorescein angiography •retinal function measured by microperimetry •biomarkers of endothelial dysfunction •microalbuminuria •beta-cell-function ;Primary end point(s): Changes in myocardial lipid content (assessed by MR-spectroscopy) ;Timepoint(s) of evaluation of this end point: study day 28

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in: - left-ventricular function - retinopathy - microalbuminuria - beta-cell-function - biomarkers of endothelial dysfunction;Timepoint(s) of evaluation of this end point: study day 28	—

Countries

Austria

Contacts

Public ContactAbt.f.Endokrinologie&Stoffwechsel

Medizinische Universität Wien, Univ.Klinik für Innere Medizin III

yvonne.winhofer@meduniwien.ac.at00431404004311

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026