| Outcome Measures: |
Primary: Change in Glycosylated Hemoglobin (HbA1c), Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline), baseline and 26 weeks | Secondary: Percentage of Patients Achieving HbA1c <= 7%, Percentage of intent-to-treat (ITT) patients who had HbA1c \> 7% at baseline that decreased to \<= 7% at endpoint (Week 26 or early discontinuation), 26 weeks|Percentage of Patients Achieving HbA1c <= 6.5%, Percentage of ITT patients who had achieved HbA1c \<= 6.5% at endpoint (Week 26 or early discontinuation), 26 weeks|Change in Fasting Serum Glucose (FSG), Change in FSG from baseline to endpoint (26 weeks), baseline and 26 weeks|Change in Body Weight, Change in body weight from baseline to endpoint (26 weeks), baseline and 26 weeks|Change in Waist Circumference, Change in waist circumference from baseline to endpoint (26 weeks), baseline and 26 weeks|Change in Beta-cell Function, Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function., baseline and 26 weeks|Change in Insulin Sensitivity., Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S)., baseline and 26 weeks|Number of Subjects Who Experienced an Episode of Minor Hypoglycemia, Overall number of subjects who experienced an episode of minor hypoglycemia., 26 weeks|Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score, IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = "never true" to 5 = "always true.", baseline and 26 weeks|Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score, EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state., baseline and 26 weeks
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| Locations: |
Research Site, Birmingham, Alabama, United States|Research Site, Concord, California, United States|Research Site, Fresno, California, United States|Research Site, Denver, Colorado, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Mogadore, Ohio, United States|Research Site, Corvallis, Oregon, United States|Research Site, New Westminster, British Columbia, Canada|Research Site, Winnipeg, Manitoba, Canada|Research Site, Ajax, Ontario, Canada|Research Site, Cambridge, Ontario, Canada|Research Site, Windsor, Ontario, Canada|Research Site, Mexico City, Distrito Federal, Mexico|Research Site, Celaya, Guanajuato, Mexico|Research Site, Monterrey, Nuevo Leon, Mexico|Research Site, Chihuahua, Mexico|Research Site, Mexico City, Mexico|Research Site, Baia Mare, Romania|Research Site, Brasov, Romania|Research Site, Bucuresti, Romania|Research Site, Dolj, Romania|Research Site, Iasi, Romania|Research Site, Suceava, Romania|Research Site, Johannesburg, South Africa|Research Site, Pretoria, South Africa
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