| Outcome Measures: |
Primary: Fasting Intact Proinsulin, The difference of fasting intact proinsulin after 24 weeks of treatment compared to baseline., Change from baseline at 24 weeks | Secondary: Weight, To evaluate the changes of weight after 24 weeks of treatment compared to baseline., Baseline and after 24 weeks of treatment.|hsCRP, To evaluate changes of hsCRP after 24 weeks of treatment compared to baseline., Baseline and after 24 weeks of treatment.|Adiponectin, To evaluate changes of adiponectin after 24 weeks of treatment compared to baseline., Baseline and after 24 weeks of treatment.|MMP-9, To evaluate changes of MMP-9 after 24 weeks of treatment compared to baseline., Baseline and after 24 weeks of treatment.|OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks, To evaluate changes of OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes) after 24 weeks of treatment compared to baseline., Baseline and after 24 weeks of treatment.|HOMA-IR score, To evaluate changes of HOMA-IR score after 24 weeks of treatment compared to baseline., Baseline and after 24 weeks of treatment.|HbA1c, To evaluate changes of HbA1C after 24 weeks of treatment compared to baseline., Baseline and after 24 weeks of treatment.|Weight, To evaluate changes of weight after 12 weeks of treatment compared to baseline and compared to 24 weeks., After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.|hsCRP, To evaluate changes of hsCRP after 12 weeks of treatment compared to baseline and compared to 24 weeks., After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.|Adiponectin, To evaluate changes of adiponectin after 12 weeks of treatment compared to baseline and compared to 24 weeks., After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.|Fasting intact Proinsulin, To evaluate changes of fasting intact proinsulin after 12 weeks of treatment compared to baseline and compared to 24 weeks., After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.|Glucose, To evaluate changes of Glucose after 12 weeks of treatment compared to baseline and compared to 24 weeks., After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.|HbA1c, To evaluate changes of HbA1c after 12 weeks of treatment compared to baseline and compared to 24 weeks., After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.|Responder rate, To investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates)., After 24 weeks of treatment compared to baseline.|Hypoglycemic events., Hypoglycemic events defined as blood glucose below 63 mg/dl., Baseline up to 24 weeks.
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