The mean age across these studies was approximately 54 years with about 15% above 65
years. The majority of patients were White, comprising approximately 70% of the
population. There was a fairly even distribution of male and female patients. The mean
duration of diabetes ranged from 3.6 to about five years across the treatment groups.
This variation was reflective of the 10 mgs dose only being included in some of the phase
events including deaths, certain AEs, and infrequent laboratory abnormalities. We
conducted analysis for the following study periods: the short-term, 24-week period,
excluding rescue therapy in order to avoid confounding a rescue treatment. Short-term
24-week periods including rescue therapy in order to address imbalances and exposure to
blinded study medication across treatment groups. The short-term plus long-term periods
to provide the most complete longitudinal experience. This is particularly valuable for
the evaluation of infrequent events and to understand effects with long-term repeated
and initial combination studies where treatment naive patients were enrolled. Patients in
the add-on combination studies had longer mean duration of diabetes. Patients entered
with a broad range of A1c values reflecting varying degrees of glycemic control by study.
Approximately 17% of patients had mild renal impairment as estimated using the
Cockroft-Gault formula. Approximately 16% to 17% of patients had a history of
microvascular complications upon study entry.
The phase 2b/3 program included a range of patients with type 2 diabetes.
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,