and then for Liraglutide for tomorrow. That first treatment period is called the short-term
period for Saxagliptin; again this is the typical 24-week core Phase 3 trials for type 2
diabetes products. The second treatment period is called the short-term and the long-term
periods. Patients entered the long-term period after either completing the short-term
period or upon requiring glycemic rescue sometime during the short-term period. This
long-term period was double blind, patients remained on their original randomized
treatment and these periods were non-voluntary. In other words, patients can’t be asked,
do you want to continue in this extension or not, patients did continue.
conducted on two treatment periods. The first treatment period would be the randomized
controlled periods for all completed phase 2/phase 3 trials up until the primary efficacy
time point for hemoglobin A1c. For drugs developed for type 2 diabetes, these phase 3
trials are typically 24 weeks in duration. For a second treatment period we wanted
applicants to also investigate cardiovascular safety including the patients who continued
beyond the primary hemoglobin A1c time point provided that the data after this time
point was controlled and remained randomized.
“Population B”. Again “Population A” is that typical 24-week treatment period.
“Population B” includes patients who have continued beyond their treatment period in
Let’s look at what these treatment periods are for Saxagliptin for today
For Liraglutide, the two treatment periods are called “Population A” and
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FDA requested that both applicants re-analyze their data and we specified the types of
statistical analyses we would want to be used, the patient populations on which these
statistical tests should be done, and what the endpoints should be. I would like to walk
you through all of that in the next few minutes.
First the FDA asked that these cardiovascular safety analyses be