Lantus Effect on Myocardial Glucose Metabolism in T2

Study Overview
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Brief Summary
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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).

Official Title
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Pilot Study for the Evaluation of the Effects of Insulin Treatment on Myocardial Function, Perfusion, and Glucose Metabolism in Patients With Primary Left Ventricular Dysfunction and Type 2 Diabetes.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin glargine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin glargine|once a daily, sc injection, 100IU/ml|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of insulin treatment on myocardial function, perfusion and glucose metabolism. |  | assessed before and after treatment | 
| adverse events |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of myocardial structure and left ventricular systolic and diastolic function |  | at baseline and at the end of the study |