糖尿病治疗三重奏到八重奏.pptVIP

* * * * * * * Move the p to middle? * * * * * * * * * * * * * * * * * * * * * * * * * * * Required DISCUSSION POINTS: --87% of the subjects who completed the 30-week placebo-controlled, double-blind, Phase 3 studies chose to continue in open-label extension (OLE) studies. --All subjects were given 5 mcg BYETTA for the first 4 weeks of the OLE (overall, Weeks 30 to 34), after which they received 10 mcg BYETTA for the remainder of their participation in the OLE. --Shown is 82-week data (30 weeks from placebo-controlled, double-blind study and 52 weeks from OLE) for 393 patients. --Of the 1446 subjects randomized to the three 30 week, blinded, placebo-controlled trials, 1125 completed and were eligible for enrollment into the open label extension studies (OLE). --Of the 1125 subjects, 977 (87%) enrolled into the OLEs. At the time of this data analysis, 795 had completed treatment through 52 weeks and 393 had completed treatment through 82 weeks. --Using the intent-to-treat (ITT) and Last Observation Carried Forward (LOCF) analysis method, the 977 ITT population had A1C and weight reductions at 82 weeks consistent with the 82-week completer population shown here. --Placebo cohort upon receiving BYETTA showed an immediate decrease of A1C similar to that observed with BYETTA treatment in the first 30 weeks. --Mean A1C reductions from baseline were very similar at 82 weeks (at least -1.1%) for all three original study treatment groups. --For patients receiving 10 mcg BYETTA for 82 weeks, 51% achieved an A1C of ?7% at 82 weeks. SLIDE BACKGROUND: --The slight upward trend seen for both the placebo and BYETTA treatment groups from Weeks 18 to 30 likely represents an initial study effect that disappears over time, and is similar in magnitude to the decrease in A1C during the 4-week placebo lead-in period. * * * Required DISCUSSION POINTS: --87% of the subjects who completed the 30-week placebo-controlled, double-blind, Phase 3 studies chose to continue in open-label e