Outcome measure of secondary objective was modified to specify “major” hypoglycemia. Insulin glargine, metformin, and rescue therapy would be sourced locally. Exclusion criterion #25 was included as inclusion criterion #9. Cut off for serum calcitonin concentration was decreased to 40 pg/mL. Tobacco, caffeine, and strenuous exercise were added to the list of restrictions 24 hours prior to each visit. Discontinuation procedures were amended to include a review when the Investigator deemed it necessary to temporarily stop and re-start study medication. Discontinued patients were required to complete the Follow-up visit (Visit 15). Discontinued patients who had symptoms of hypoglycemia were to record glucose measurements and episode details in the patient diary. Study Plan was updated to clarify when study diary was given out, procedures for collecting study diary, when study medication was dispensed and used/unused medication was collected. Text was added to differentiate procedures for Early Termination and Rescue Visits, to indicate IVRS should be called on the day of consent, to clarify that patients undergoing rescue therapy were to perform the 6 point SMBG profile before returning for Rescue Visit, to indicate that staff monitored study medication administration at study visits, and to indicate when MTTs should be performed. Text regarding the MTT was updated to include instruction on MTT timing and for how the MTT should have been performed. BP measurement instructions were modified. Investigators should contact medical monitor if a patient developed a liver function test abnormality. Hy’s Law text was updated to state that cases meeting any of the identification criteria required an unscheduled laboratory draw. Hypoglycemia assessment was updated with criteria for classification. The Sponsor should have been contacted regarding hypoglycemia events. Added use of SU as a stratification factor for exploratory analyses. Clarified assessment of causality for AEs.

The proportion of patients rescued or discontinued for lack of glycemic control at Week 28 was added as an exploratory outcome measure. Inclusion criterion #7 was clarified to state that patients may only take basal insulin glargine once daily. Exclusion criterion #32 was amended to include participation in an interventional clinical trial and to clarify that only administration of an investigational drug would have rendered a patient as ineligible. The Study Plan and Timing of Procedures was updated. This update clarified study visit windows, when used/unused study medication was to be collected, when training for study drug administration was to be received by the patient, and visits when rescue medication could have been dispensed. Review of potential CV event triggers was added to all visits where AEs and concomitant medication were reviewed. Text was added to indicate that metformin should be taken with the next meal, and does not need to be taken at the study center, and that urine should be collected right before time 0 of the meal tolerance test. Text was added to indicate that study medication may be dispensed at a Rescue Visit. Text was added to clarify that potential CV event triggers would be reviewed at specified study visits. Text was added to indicate that urine was collected right before time 0 of the MTT. Text was amended to indicate that antibody results would be presented in the CSR. Text was added to clarify that the baseline physical examination data are collection at Visit 1. Text was added to clarify that there is no restriction on fathering children during the study. Text was added to describe the adjudication of cardiovascular events.