Status:
COMPLETED
Lantus Effect on Myocardial Glucose Metabolism in T2
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 diabet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00335465
Start Date
September 1 2005
End Date
June 1 2008
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Milan, Italy