[Translation] A multicenter, international, randomized, parallel, double-blind placebo-controlled study of linagliptin on cardiovascular and renal safety and renal microvascular outcomes in patients with type 2 diabetes mellitus at high vascular risk
证明与安慰剂相比利格列汀治疗的非劣效性,考察指标是2型糖尿病患者主要复合终点的任何判定要素的首次发生时间包括心血管源性死亡、非致死性中风、非致死性心肌梗死及因不稳定型心绞痛住院。若非劣效性得到证明,则将检验主要复合终点的优效性,并在优效性基础上的检验而单独考察另一目的,以评估治疗对复合肾脏终点的影响
[Translation] Demonstrate non-inferiority of linagliptin compared to placebo, as measured by time to first occurrence of any adjudicative element of the primary composite endpoint in patients with type 2 diabetes including cardiovascular death, non-fatal stroke, non-fatal Myocardial infarction and hospitalization for unstable angina. If non-inferiority is demonstrated, superiority will be tested for the primary composite endpoint, and a test based on superiority will examine another objective separately to assess the effect of treatment on the composite renal endpoint