BI 10773 Cardiovascular outcome event trial in Type 2 Diabetes Mellitus patients

Update Il y a 4 ans
Reference: EUCTR2009-016178-33

Woman and Man

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Extract

The primary endpoint is time to the first occurrence of any of the following adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke.


Inclusion criteria

  • The study will be performed in patients with type 2 diabetes mellitus and high cardiovascular risk who have insufficient glycaemic control despite diet and exercise and are either treatment naïve or receiving any antidiabetic background therapy.
  • Drug-naïve is defined as absence of any antidiabetic therapy for 12 weeks prior to randomisation