Lantus Effect on Myocardial Glucose Metabolism in T2
Diabetes Mellitus, Type 2

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria: LV systolic dysfunction (2D-Echo LVEF < 50%) with or without LV dilation (2D-Echo LV EDD > 56 mm) or left ventricular end-diastolic diameter (LVEDD) >55mm with or without LV dysfunction angiographically normal coronary arteries (< 50% vessel narrowing); newly diagnosed type 2 diabetes; previously diagnosed: OAD treated type 2 diabetic patients able to take part in the study after a one-month wash-out period and insulin treated type 2 diabetic patients able to take part in the study after one week wash-out period. Exclusion Criteria: evidence of congenital or valvular cardiac diseases, hypertrophic cardiomyopathy, overt heart failure (NYHA class III-IV); moderate to severe hypertension (diastolic aortic pressure > 100 mmHg); hypotension (systolic aortic pressure < 100 mmHg); nephropathy (serum creatinine > 3 mg/dL); other systemic and/or infective diseases; severe dyslipidemia; peripheral vasculopathy; necessity of vasoactive medical treatment in the last 48 hours; atrial fibrillation; Refusal or impossibility to give written informed consent; patients diagnosed with type 1 insulin dependent diabetes; clinically relevant cardiovascular, hepatic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult; patients with medical history positive for cerebrovascular accidents, including Transient Ischaemic Attack (TIA); women who are lactating, pregnant, or planning to become pregnant during the study; history of hypersensitivity to the investigational products or to drugs with similar chemical structures; likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol; treatment with any investigational product in the last 30 days or 5 half-lives (whichever is longer) before study entry; current use of investigational agents or participation in any other investigational studies during study period; history of drug or alcohol abuse; impaired hepatic function, as shown by Alamine AminoTransferase (ALT) > 2,5 times the upper limit of the normal laboratory range; mental condition making the subject unable to understand the nature, scope, and possible consequences of the study; patients unable to understand dosing directions; subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures; receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry; previous enrollment in the present study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis Administrative Office