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.
Investigators
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
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