Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).

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

Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.

Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)

Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study

Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.

Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.

Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).

Change in HbA1c from Baseline to Week 24

Absolute change in HbA1c from Baseline (Day -3) to Week 30 \[Week 30 - Baseline\]

Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval

Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \[i.e., clamp time 290 min to 300 min\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline \[week -2\]).

Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.

Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between

Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

Visits for this study occur at 6-mo (±2 wk) intervals until exenatide is approved for marketing.

Assess dose response effect on glucose control as measured by HbA1c among four doses (2.5 μg, 5 μg, 10 μg, and placebo) of subcutaneous injection of exenatide, twice daily before meals in the morning and evening, for 12 weeks

Change in HbA1c from Baseline study termination (Week 16)