| Outcome Measures: |
Primary: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24, Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0), baseline, 24 weeks | Secondary: Percentage of Patients Achieving HbA1c < 7.0%, Percentage of subjects whose HbA1c was \>=7.0% at baseline who achieved an HbA1c \< 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c \< 7.0% divided by total number of eligible subjects times 100), 24 weeks|Percentage of Patients Achieving HbA1c < 6.5%, Percentage of subjects whose HbA1c was \>=6.5% at baseline who achieved an HbA1c \< 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c \< 6.5% divided by total number of eligible subjects times 100), 24 weeks|Change in Fasting Blood Glucose, Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0), baseline, week 24|Change in Body Weight, Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0), baseline, week 24|Change in Total Cholesterol, Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0), baseline, week 24|Change in Low Density Lipoprotein Cholesterol (LDL-C), Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0), baseline, week 24|Change in High Density Lipoprotein Cholesterol (HDL-C), Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0), baseline, week 24|Change in Triglycerides, Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0), baseline, week 24|Change in Waist Size, Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0), baseline, week 24|Change in Waist-to-hip Ratio, Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference., baseline, week 24|7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24, Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)., baseline, week 24|Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B), Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function., baseline, week 24|Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R), Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance., baseline, week 24|Change in Serum Insulin, Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0), baseline, week 24|Change in C-peptide, Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0), baseline, week 24|Change in 1,5-anhydroglucitol, Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0), baseline, week 24
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| Locations: |
Research Site, Chiba, Japan|Research Site, Fukuoka, Japan|Research Site, Fukushima, Japan|Research Site, Hyogo, Japan|Research Site, Ibaragi, Japan|Research Site, Kanagawa, Japan|Research Site, Kumamoto, Japan|Research Site, Kyoto, Japan|Research Site, Nagano, Japan|Research Site, Oita, Japan|Research Site, Osaka, Japan|Research Site, Tokyo, Japan
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