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The mean age across these studies was approximately 54 years with about 15% above 65

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years. The majority of patients were White, comprising approximately 70% of the

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population. There was a fairly even distribution of male and female patients. The mean

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duration of diabetes ranged from 3.6 to about five years across the treatment groups.

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This variation was reflective of the 10 mgs dose only being included in some of the phase

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3 studies.

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events including deaths, certain AEs, and infrequent laboratory abnormalities. We

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conducted analysis for the following study periods: the short-term, 24-week period,

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excluding rescue therapy in order to avoid confounding a rescue treatment. Short-term

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24-week periods including rescue therapy in order to address imbalances and exposure to

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blinded study medication across treatment groups. The short-term plus long-term periods

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to provide the most complete longitudinal experience. This is particularly valuable for

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the evaluation of infrequent events and to understand effects with long-term repeated

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dosing

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and initial combination studies where treatment naive patients were enrolled. Patients in

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the add-on combination studies had longer mean duration of diabetes. Patients entered

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with a broad range of A1c values reflecting varying degrees of glycemic control by study.

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Approximately 17% of patients had mild renal impairment as estimated using the

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Cockroft-Gault formula. Approximately 16% to 17% of patients had a history of

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microvascular complications upon study entry.

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The phase 2b/3 program included a range of patients with type 2 diabetes.

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As expected, mean duration of diabetes was shorter in the monotherapy

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The remainder of the safety presentation will provide an overview of the

following topics: overall adverse events, serious AEs, and discontinuations for AEs,

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