| Outcome Measures: |
Primary: Change in Glycosylated Hemoglobin (HbA1c), Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated., baseline and 30 weeks | Secondary: Percentage of Patients Achieving HbA1c <=7%, Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 30 (percentage = \[number of subjects with HbA1c \<=7% at week 30 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%)., baseline and 30 weeks|Percentage of Patients Achieving HbA1c <=6.5%, Percentage of patients in each arm who had HbA1c \>6.5% at baseline and had HbA1c \<=6.5% at week 30 (percentage = \[number of subjects with HbA1c \<=6.5% at week 30 divided by number of subjects with HbA1c \>6.5% at baseline\] \* 100%)., baseline and 30 weeks|Change in Fasting Serum Glucose, Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline), baseline and 30 weeks|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile, Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline), baseline and 30 weeks|Change in Total Cholesterol, Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline), baseline and 30 weeks|Change in Low Density Lipoprotein (LDL) Cholesterol, Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline), baseline and 30 weeks|Change in High Density Lipoprotein (HDL) Cholesterol, Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline), baseline and 30 weeks|Change in Triglycerides, Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline), baseline and 30 weeks|Change in Body Weight, Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline), baseline and 30 weeks|Change in Waist Circumference, Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline), baseline and 30 weeks|Change in Daily Insulin Dose, Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline), baseline and 30 weeks|Change in Daily Insulin Dose (on a Per Body Weight Basis), Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline), baseline and 30 weeks|Change in Systolic Blood Pressure (SBP), Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline), baseline and 30 weeks|Change in Diastolic Blood Pressure (DBP), Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline), baseline and 30 weeks|Minor Hypoglycemia Rate Per Year, Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL)., baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Percentage of Subjects Experiencing Minor Hypoglycemia, Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL)., baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
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| Locations: |
Research Site, Peoria, Arizona, United States|Research Site, Phoenix, Arizona, United States|Research Site, Buena Park, California, United States|Research Site, Concord, California, United States|Research Site, Fresno, California, United States|Research Site, Greenbrae, California, United States|Research Site, La Mesa, California, United States|Research Site, Lancaster, California, United States|Research Site, Northridge, California, United States|Research Site, Palm Springs, California, United States|Research Site, Salinas, California, United States|Research Site, Hollywood, Florida, United States|Research Site, Jacksonville, Florida, United States|Research Site, Atlanta, Georgia, United States|Research Site, Honolulu, Hawaii, United States|Research Site, Idaho Falls, Idaho, United States|Research Site, Des Moines, Iowa, United States|Research Site, Wichita, Kansas, United States|Research Site, Baton Rouge, Louisiana, United States|Research Site, Lafayette, Louisiana, United States|Research Site, Matairie, Louisiana, United States|Research Site, Boston, Massachusetts, United States|Research Site, Minneapolis, Minnesota, United States|Research Site, Chesterfield, Missouri, United States|Research Site, St Louis, Missouri, United States|Research Site, Omaha, Nebraska, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Berkeley Heights, New Jersey, United States|Research SIte, Teaneck, New Jersey, United States|Research Site, Alburquerque, New Mexico, United States|Research SIte, New York, New York, United States|Research Site, Durham, North Carolina, United States|Research Site, Bend, Oregon, United States|Research Site, Dallas, Texas, United States|Research Site, El Paso, Texas, United States|Research Site, Georgetown, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Richmond, Virginia, United States|Research Site, Vancouver, Washington, United States|Research Site, Kenosha, Wisconsin, United States|Research Site, Athens, Greece|Research Site, Thessaloniki, Greece|Research Site, Holon, Israel|Research Site, Kfar Sava, Israel|Research Site, Tel Hashomer, Israel|Research Site, Coatzacoalcos, Mexico|Research Site, Mexico, Mexico|Research Site, Monterrey, Mexico|Research Site, Carolina, Puerto Rico|Research Site, Hato Rey, Puerto Rico|Research Site, Ponce, Puerto Rico|Research Site, San Juan, Puerto Rico|Research Site, Birmingham, United Kingdom|Research Site, Guildford, United Kingdom|Research Site, Leicester, United Kingdom|Research Site, Livingston, United Kingdom|Research Site, Middlesbrough, United Kingdom|Research Site, Swansea, United Kingdom|Research Site, Torquay, United Kingdom
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