Two blinded interim analyses (IAs) were planned, one when approximately 40% of subjects had been randomized and completed through month 6, and the other when over 60% of the subjects had been randomized and completed through month 6. The ITT population was used for the analyses conducted in each IA. The IA was directed and conducted by an independent statistician, who was not involved in the trial conduct other than this IA. The main purpose of the IAs was to assess the assumption made concerning the standard deviation in the sample size calculation for the primary end-point (mean change in HbA1c). Two such IAs were planned because the trial started earlier in the USA than in India, so the first IA was more likely to reflect the results from the USA population, while the second IA was more likely to reflect the results from the India population. For each IA, the independent statistician used the blinded data, the observed pooled standard deviation, and the other original assumptions noted in the sample size determination (e.g. Power, Type I error rate) to recalculate the sample size. Based on the documented sample size re-calculation and the observed dropout rate, the intent was that the independent statistician could recommend a new, larger sample size to the sponsor; however, in neither IA was this necessary.