| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (Week 12)., The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline., Baseline and Week 12. | Secondary: Change From Baseline in Glycosylated Hemoglobin (Week 2)., The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline., Baseline and Week 2.|Change From Baseline in Glycosylated Hemoglobin (Week 4)., The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline., Baseline and Week 4.|Change From Baseline in Glycosylated Hemoglobin (Week 8)., The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline., Baseline and Week 8.|Change From Baseline in Fasting Plasma Glucose (Week 2)., The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline., Baseline and Week 2|Change From Baseline in Fasting Plasma Glucose (Week 4)., The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline., Baseline and Week 4.|Change From Baseline in Fasting Plasma Glucose (Week 8)., The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline., Baseline and Week 8.|Change From Baseline in Fasting Plasma Glucose (Week 12)., The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline., Baseline and Week 12.|Change From Baseline in Fasting C-peptide (Week 2)., The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline., Baseline and Week 2.|Change From Baseline in Fasting C-peptide (Week 4)., The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline., Baseline and Week 4.|Change From Baseline in Fasting C-peptide (Week 8)., The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline., Baseline and Week 8.|Change From Baseline in Fasting C-peptide (Week 12)., The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline., Baseline and Week 12.|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value)., The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal., Baseline and Week 12.|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2))., The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal., Baseline and Week 12.|Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2))., The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal., Baseline and Week 12|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)., The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal., Baseline and Week 12.|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2))., The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal., Baseline and Week 12
|
