| Outcome Measures: |
Primary: Mean Change From Baseline in A1C at Month 6, Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values., Baseline and Month 6 | Secondary: Mean Change From Baseline in A1C at Month 4, Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values., Baseline and Month 4|Mean Change From Baseline in A1C at Month 12, Change from baseline was calculated as the Month 12 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values., Baseline and Month 12|Number of Subjects Achieving A1C Target at Month 4, A1C responders were described as subjects having achieved A1C less than 7 percent at Month 4, with LOCF from Month 2., Month 4|Number of Subjects Achieving A1C Target at Month 6, A1C responders were described as subjects having achieved A1C less than 7 percent at Month 6, with LOCF from Month 2., Month 6|Number of Subjects Achieving A1C Target at Month 12, A1C responders were described as subjects having achieved A1C less than 7 percent at Month 12 with LOCF from Month 2., Month 12|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 4, Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values., Baseline and Month 4|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6, Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values., Baseline and Month 6|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12, Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2 for withdrawn subjects or missing values., Baseline and Month 12|Number of Subjects Achieving FPG Target at Month 4, FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 4 with LOCF from Month 2., Month 4|Number of Subjects Achieving FPG Target at Month 6, FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 6 with LOCF from Month 2., Month 6|Number of Subjects Achieving FPG Target at Month 12, FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 12 with LOCF from Month 2., Month 12|Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 6, Change from baseline was calculated as the Month 6 value minus the baseline value, with LOCF from Month 2. The UKPDS (United Kingdom Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to high-density lipoprotein (HDL) ratio at a specified visit. The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event., Baseline and Month 6|Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 12, Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2. The UKPDS (U.K. Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to HDL ratio at a specified visit. The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event., Baseline and Month 12|Mean Change From Baseline in C-reactive Protein (CRP) at Month 6, Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. CRP was only done at baseline, months 6 and 8. The test was optional and performed only by participating sites., Baseline and Month 6|Mean Change From Baseline in C-reactive Protein (CRP) at Month 12, Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. CRP was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites., Baseline and Month 12|Mean Change From Baseline in Adiponectin at Month 6, Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites., Baseline and Month 6|Mean Change From Baseline in Adiponectin at Month 12, Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites., Baseline and Month 12
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