Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00335465 |
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).
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: Insulin glargine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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. |
Enrollment: | 15 |
Study Start Date: | September 2005 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | HOE901_4053, EUDRACT # : 2004-002729-34 |
Study First Received: | June 8, 2006 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00335465 History of Changes |
Health Authority: | Italy: Ministry of Health |
Ventricular Dysfunction Metabolic Diseases Heart Diseases Diabetes Mellitus Endocrine System Diseases Insulin Hypoglycemic Agents |
Diabetes Mellitus, Type 2 Glargine Ventricular Dysfunction, Left Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Ventricular Dysfunction Metabolic Diseases Heart Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Pharmacologic Actions |
Insulin Hypoglycemic Agents Diabetes Mellitus, Type 2 Glargine Ventricular Dysfunction, Left Cardiovascular Diseases Glucose Metabolism Disorders |