AN INTERNATIONAL, MULTICENTER, LARGE SIMPLE TRIAL (LST) TO EVALUATE THE LONG-TERM PULMONARY AND CARDIOVASCULAR SAFETY OF EXUBERA® IN PATIENTS WITH DIABETES MELLITUS

Update Il y a 4 ans
Reference: EUCTR2006-001996-39

Woman and Man

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Extract

The primary objective of this study is to estimate the relative risk of a persistent decline in FEV1 exceeding 20% from baseline among subjects with diabetes randomized to Exubera as compared with those not randomized to Exubera. For both treatment groups, a persistent decline in FEV1 exceeding 20% from baseline is defined as an observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline in FEV1 exceeding 20% from baseline.


Inclusion criteria

  • Diabetes Mellitus Type I and Type II