Lantus Effect on Myocardial Glucose Metabolism in T2

Launched by SANOFI · Jun 8, 2006

Keywords

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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.