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and then for Liraglutide for tomorrow. That first treatment period is called the short-term

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period for Saxagliptin; again this is the typical 24-week core Phase 3 trials for type 2

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diabetes products. The second treatment period is called the short-term and the long-term

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periods. Patients entered the long-term period after either completing the short-term

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period or upon requiring glycemic rescue sometime during the short-term period. This

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long-term period was double blind, patients remained on their original randomized

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treatment and these periods were non-voluntary. In other words, patients can’t be asked,

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do you want to continue in this extension or not, patients did continue.

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conducted on two treatment periods. The first treatment period would be the randomized

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controlled periods for all completed phase 2/phase 3 trials up until the primary efficacy

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time point for hemoglobin A1c. For drugs developed for type 2 diabetes, these phase 3

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trials are typically 24 weeks in duration. For a second treatment period we wanted

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applicants to also investigate cardiovascular safety including the patients who continued

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beyond the primary hemoglobin A1c time point provided that the data after this time

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point was controlled and remained randomized.

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“Population B”. Again “Population A” is that typical 24-week treatment period.

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“Population B” includes patients who have continued beyond their treatment period in

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Let’s look at what these treatment periods are for Saxagliptin for today

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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

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statistical analyses we would want to be used, the patient populations on which these

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statistical tests should be done, and what the endpoints should be. I would like to walk

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you through all of that in the next few minutes.

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First the FDA asked that these cardiovascular safety analyses be

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