lantus effect on myocardial glucose metabolism in t2

Conditions: Diabetes Mellitus, Type 2

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).


Eligibility criteria:
inclusion criteria: * lv systolic dysfunction (2d-echo lvef \ 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.