| Outcome Measures: |
Primary: Change from Baseline in Metabolic Rate of Midazolam (CYP3A4) at Week 3., Change in activity of the drug metabolizing enzyme CYP3A4 following treatment with the glucose lowering drug metformin in 3 weeks. Assessment of the change is based on a change in the metabolic rate, which is the ratio between the concentration of midazolam and its primary metabolite is plasma (Probe drug for CYP3A4)., Baseline and Week 3.|Change from Baseline in Metabolic Rate of Midazolam (CYP3A4) at Week 12., Change in activity of the drug metabolizing enzyme CYP3A4 following treatment with the glucose lowering drug metformin in 12 weeks. Assessment of the change is based on a change in the metabolic rate, which is the ratio between the concentration of midazolam and its primary metabolite is plasma (Probe drug for CYP3A4)., Baseline and Week 12. | Secondary: Change from Baseline in Metabolic Rate of Caffeine (CYP1A2) at Week 3., Change in activity of the drug metabolizing enzymes CYP1A2 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug caffeine., Baseline and Week 3.|Change from Baseline in Metabolic Rate of Caffeine (CYP1A2) at Week 12., Change in activity of the drug metabolizing enzymes CYP1A2 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug caffeine., Baseline and Week 12.|Change from Baseline in Metabolic Rate of Efavirenz (CYP2B6) at Week 3., Change in activity of the drug metabolizing enzymes CYP2B6 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Efavirenz., Baseline and Week 3.|Change from Baseline in Metabolic Rate of Efavirenz (CYP2B6) at Week 12., Change in activity of the drug metabolizing enzymes CYP2B6 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Efavirenz., Baseline and Week 12.|Change from Baseline in Metabolic Rate of Losartan (CYP2C9) at Week 3., Change in activity of the drug metabolizing enzymes CYP2C9 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Losartan., Baseline and Week 3.|Change from Baseline in Metabolic Rate of Losartan (CYP2C9) at Week 12., Change in activity of the drug metabolizing enzymes CYP2C9 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Losartan., Baseline and Week 12.|Change from Baseline in Metabolic Rate of Omeprazole (CYP2C19) at Week 3., Change in activity of the drug metabolizing enzymes CYP2C19 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Omeprazole., Baseline and Week 3.|Change from Baseline in Metabolic Rate of Omeprazole (CYP2C19) at Week 12., Change in activity of the drug metabolizing enzymes CYP2C19 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Omeprazole., Baseline and Week 12.|Change from Baseline in Metabolic Rate of Metoprolol (CYP2D6) at Week 3., Change in activity of the drug metabolizing enzymes CYP2D6 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Metoprolol., Baseline and Week 3.|Change from Baseline in Metabolic Rate of Metoprolol (CYP2D6) at Week 12., Change in activity of the drug metabolizing enzymes CYP2D6 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Metoprolol., Baseline and Week 12.|Change from Baseline in HbA1c at Week 3., Change in the regulation of blood glucose over time assessed by HbA1c, Baseline and Week 3.|Change from Baseline in HbA1c at Week 12., Change in the regulation of blood glucose over time assessed by HbA1c, Baseline and Week 12.|Change from Baseline in insulin resistance at Week 3., An oral glucose tolerance test will be performed and glucose, insulin and c-peptide will be measured and combined by the Homeostatic Model Assessment (HOMA) to report insulin resistance., Baseline and Week 3.|Change from Baseline in insulin resistance at Week 12., An oral glucose tolerance test will be performed and glucose, insulin and c-peptide will be measured and combined by the Homeostatic Model Assessment (HOMA) to report insulin resistance., Baseline and Week 12.|Change from Baseline in Interleukin-1-B at Week 3., Change in patients inflammatory status assessed by measurement of Interleukin-1-B., Baseline and Week 3.|Change from Baseline in Interleukin-1-B at Week 12., Change in patients inflammatory status assessed by measurement of Interleukin-1-B., Baseline and Week 12.|Change from Baseline in Interleukin-2 at Week 3., Change in patients inflammatory status assessed by measurement of Interleukin-2., Baseline and Week 3.|Change from Baseline in Interleukin-2 at Week 12., Change in patients inflammatory status assessed by measurement of Interleukin-2., Baseline and Week 12.|Change from Baseline in Interleukin-6 at Week 3., Change in patients inflammatory status assessed by measurement of Interleukin-6., Baseline and Week 3.|Change from Baseline in Interleukin-6 at Week 12., Change in patients inflammatory status assessed by measurement of Interleukin-6., Baseline and Week 12.|Change from Baseline in Interleukin-10 at Week 3., Change in patients inflammatory status assessed by measurement of Interleukin-10., Baseline and Week 3.|Change from Baseline in Interleukin-10 at Week 12., Change in patients inflammatory status assessed by measurement of Interleukin-10., Baseline and Week 12.|Change from Baseline in Interferon-a at Week 3., Change in patients inflammatory status assessed by measurement of Interferon-a., Baseline and Week 3.|Change from Baseline in Interferon-a at Week 12., Change in patients inflammatory status assessed by measurement of Interferon-a., Baseline and Week 12.|Change from Baseline in Interferon-B at Week 3., Change in patients inflammatory status assessed by measurement of Interferon-B., Baseline and Week 3.|Change from Baseline in Interferon-B at Week 12., Change in patients inflammatory status assessed by measurement of Interferon-B., Baseline and Week 12.|Change from Baseline in Interferon-y at Week 3., Change in patients inflammatory status assessed by measurement of Interferon-y., Baseline and Week 3.|Change from Baseline in Interferon-y at Week 12., Change in patients inflammatory status assessed by measurement of Interferon-y., Baseline and Week 12.|Change from Baseline in Tumor Necrosis Factor-a at Week 3., Change in patients inflammatory status assessed by measurement of Tumor Necrosis Factor-a., Baseline and Week 3.|Change from Baseline in Tumor Necrosis Factor-a at Week 12., Change in patients inflammatory status assessed by measurement of Tumor Necrosis Factor-a., Baseline and Week 12.|Change from Baseline in High Sensitivity C-Reactive Protein at Week 3., Change in patients inflammatory status assessed by measurement of High Sensitivity C-Reactive Protein., Baseline and Week 3.|Change from Baseline in High Sensitivity C-Reactive Protein at Week 12., Change in patients inflammatory status assessed by measurement of High Sensitivity C-Reactive Protein., Baseline and Week 12.
|
