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comprised of what the Sponsor termed short-term and long-term periods; the long-term

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period essentially being an extension phase. At the time of the NDA submission, the

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long-term periods were still ongoing. Still data from the long-term periods were included

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in the NDA and the 120-day safety update. All six-core phase 2I studies shared a

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common study design. A screening period followed by a placebo lead-in period and then

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a 24-week so called short-term period. The FDA draft guidance on diabetes from

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February 2008 refers to the six-month placebo controlled phase as well as an extension

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phase of six to twelve months, which the Sponsor has termed the long-term period.

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2b dose finding study and a phase 2I mechanism of action study. While the bulk of

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data arises from the core phase 2I studies, the safety data that will be presented includes

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all eight studies. These two studies were of shorter duration and enrolled smaller

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numbers of subjects and therefore contribute less.

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was notable and the double blind treatment was continued along with open label rescue

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medication that I will detail in upcoming slides. The Sponsor incorporated a rescue

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scheme in the short-term and long-term periods for subjects with inadequate glycemic

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control on their randomized treatment. Therefore subjects could enter the long-term

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period in one of two ways, by either completing the 24 week short-term period without

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requiring rescue, or secondly requiring rescue during the 24 week short-term period and

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then entering the long-term period.

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Now specifically focusing on the core phase 2I studies, all six were

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In this clinical development program, the extension or long-term phase

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blind in addition to open label rescue. The long-term period was not voluntary and the

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subjects were not asked at the end of the short-term period whether they wanted to

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For rescued subjects, treatment in the long-term period remained double-

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