Skip to main content
Clinical Trials/EUCTR2012-001208-39-AT
EUCTR2012-001208-39-AT
Active, not recruiting
Not Applicable

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

Medizinische Universität Wien, Univ.Klinik für Innere Medizin III, Abt.f.Endokrinologie und Stoffwechsel0 sitesApril 17, 2012
Conditionsdiabetes mellitus type 2, inadequate metabolic control, indication for insulin therapymyocardial lipid accumulation and left-ventricular function, retinal changes, microabluminuria, beta-cell-function, endothelial dysfunctionMedDRA version: 14.1Level: PTClassification code 10012607Term: Diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: PTClassification code 10012689Term: Diabetic retinopathySystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: HLTClassification code 10012654Term: Diabetic complications cardiovascularSystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 14.1Level: PTClassification code 10012647Term: Diabetic cardiomyopathySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: HLTClassification code 10012658Term: Diabetic complications renalSystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 14.1Level: HLTClassification code 10012657Term: Diabetic complications ophthalmicSystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 14.1Level: PTClassification code 10054044Term: Diabetic microangiopathySystem Organ Class: 10047065 - Vascular disordersMedDRA version: 14.1Level: HLGTClassification code 10012653Term: Diabetic complicationsSystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
diabetes mellitus type 2, inadequate metabolic control, indication for insulin therapymyocardial lipid accumulation and left-ventricular function, retinal changes, microabluminuria, beta-cell-function, endothelial dysfunction
Sponsor
Medizinische Universität Wien, Univ.Klinik für Innere Medizin III, Abt.f.Endokrinologie und Stoffwechsel
Status
Active, not recruiting
Last Updated
13 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 17, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medizinische Universität Wien, Univ.Klinik für Innere Medizin III, Abt.f.Endokrinologie und Stoffwechsel

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

Similar Trials