Lantus Effect on Myocardial Glucose Metabolism in T2

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.