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Tracking Information | |||||
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First Received Date † | June 8, 2006 | ||||
Last Updated Date | July 1, 2008 | ||||
Start Date † | September 2005 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
effect of insulin treatment on myocardial function, perfusion and glucose metabolism. | ||||
Change History | Complete list of historical versions of study NCT00335465 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
changes of myocardial structure and left ventricular systolic and diastolic function [ Time Frame: at baseline and at the end of the study ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Lantus Effect on Myocardial Glucose Metabolism in T2 | ||||
Official Title † | Pilot Study for the Evaluation of the Effects of Insulin Treatment on Myocardial Function, Perfusion, and Glucose Metabolism in Patients With Primary Left Ventricular Dysfunction and Type 2 Diabetes. | ||||
Brief Summary | The primary objective of the present study is to assess changes of myocardial glucose uptake (MGU) during clamp studies using positron emission tomography (PET) scanning in patients with type 2 diabetes and idiopathic left ventricular dysfunction (LVD). The secondary objectives of the study are: assessment of changes of myocardial microcirculation at rest and during adenosine stimulation using PET; assessment of changes in myocardial structure and function evaluated by magnetic resonance imaging (MRI); assessment of glycaemic control by measurement of HbA1c, fasting blood glucose and insulin levels; assessment of safety (adverse event profile, laboratory data). |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Diabetes Mellitus, Type 2 | ||||
Intervention † | Drug: Insulin glargine | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 15 | ||||
Completion Date | |||||
Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
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Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Italy | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00335465 | ||||
Responsible Party | Medical Affairs Study Director, sanofi-aventis | ||||
Secondary IDs †† | EUDRACT # : 2004-002729-34 | ||||
Study Sponsor † | Sanofi-Aventis | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Sanofi-Aventis | ||||
Verification Date | July 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |