Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)

The number of participants was determined based on sample size calculations using parameter estimates from prior study H8O-MC-GWAP (NCT00099320), with change from baseline HbA1c as the primary efficacy measure. Primary analysis is reported for intent to treat population (ITT), last observation carried forward (LOCF).

Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation)

Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.

Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation)

Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.

Change in FSG from baseline to endpoint (26 weeks)

Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.

Change in body weight from baseline to endpoint (26 weeks)

Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.

Change in waist circumference from baseline to endpoint (26 weeks)

Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.

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.

Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.

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).

Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.

Overall number of subjects who experienced an episode of minor hypoglycemia.

Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.

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."

Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.

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.

Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.