| Outcome Measures: |
Primary: Change in glycosylated Hemoglobin (HbA1c) for metformin background patients, Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline is calculated as the week 26 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage, the change from baseline is also a percentage., Baseline and 26 weeks|Change in glycosylated Hemoglobin (HbA1c) for treatment naive patients, Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline is calculated as the week 26 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage, the change from baseline is also a percentage., Baseline and 26 weeks|Change from baseline in acute insulin response to glucose (AIRg) for metformin background patients, Change in baseline in acute insulin response to glucose at week 26, Baseline and 26 weeks|Change from baseline in acute insulin response to glucose (AIRg) for treatment naive patients, Change in baseline in acute insulin response to glucose at week 26, Baseline and 26 weeks | Secondary: Change in glycosylated Hemoglobin (HbA1c) to <7.0%, Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline is calculated as the week 26 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage, the change from baseline is also a percentage. Percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%., Baseline and 26 weeks|Change from baseline in Body weight, Change in body weight at week 26, Baseline and 26 weeks|Change from baseline in fasting plasma glucose, Change in baseline in fasting plasma glucose at week 26, Baseline and 26 weeks|Change from baseline in Beta-cell function Index, Change in baseline in beta cell function index at week 26. Beta-cell function Index is a measure of their capacity to respond to elevated blood glucose levels, Baseline and 26 weeks|Change from baseline in insulin sensitivity index (ISI or Si), Change in baseline in insulin sensitivity at week 26, Baseline and 26 weeks|Change from baseline in glycosylated albumin (GA): glycosylated Hemoglobin A1c (HbA1c) ratio, Change in baseline in glycosylated albumin (GA): glycosylated Hemoglobin A1c (HbA1c) at week 26. GA:HbA1c ratio provides a measure of post-prandial excursion, Baseline and 26 weeks|Change from baseline in HOMA2-b%, Change in baseline in HOMA of Beta-cell function index at week 26, Baseline and 26 weeks|Change from baseline in HOMA-IR, Change in baseline in HOMA-IR at week 26. HOMA-IR is a measure of insulin resistance., Baseline and 26 weeks|Leptin/Adiponectin ratio, Change in baseline in Leptin/Adiponectin ratio. Indicator of insulin resistance, Baseline and 26 weeks|Change from baseline in Atherogenic Index (AI), Change in baseline in Atherogenic Index at week 26. Atherogenic Index (AI) is a predictor of cardiovascular risk, Baseline and 26 weeks|Change from baseline in glycosylated albumin (GA), Change in baseline in glycosylated albumin (GA) at week 26, Baseline and 26 weeks|Change from baseline in Leptin, Change in baseline in Leptin at week 26, Baseline and 26 weeks|Change from baseline in Adiponectin, Change in baseline in Adiponectin at week 26, Baseline and 26 weeks
|
