Boehringer Ingelheim Roxane, Inc.

To evaluate the efficacy and safety of linagliptin 5 mg once daily (q.d.) compared with placebo in Chinese patients with type 2 diabetes who have inadequate glycemic control on insulin alone or insulin plus metformin.

To demonstrate non-inferiority of linagliptin compared to placebo in terms of the time to first occurrence of any component of the primary composite endpoint in patients with type 2 diabetes: death from cardiovascular causes, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for unstable angina. If non-inferiority is demonstrated, superiority of the primary composite endpoint will be tested, and a separate objective will be investigated based on superiority to assess the effect of treatment on the composite renal endpoint.