课件：糖尿病治疗——三重奏到八重奏.pptVIP

* 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 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 weight similar to that observed with BYETTA treatment in the first 30 weeks. --Mean body weight reductions mediated by BYETTA during the first 30 weeks were sustained and appeared to be progressive through 82 weeks. SLIDE BACKGROUND: --Diet and exercise counseling were not provided during the study. * * Elevated rates of basal hepatic glucose output (bHGO) are significantly correlated with the fasting serum glucose (FSG) level in subjects with non-insulin-dependent diabetes mellitus (NIDDM). This observation suggests that bHGO is a major determinant of the severity of the diabetic state in these subjects. In addition, basal glucagon levels (bGL) are higher in these diabetics than in control subjects, despite the concurrent basal hyperglycemia and hyperinsulinemia, two factors known to suppress glucagon secretion. Although bGL is responsible for sustain