Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Patients With Type 2 Diabetes Treated With Metformin and a Sulfonylurea

Glycemic control in subjects with type 2 diabetes treated with metformin and a sulfonylurea plus exenatide or placebo (ITT population) A: A1C values over the course of the study (raw data). B: Change in A1C over 30 weeks. *Adjusted P < 0.0001 compared with placebo. Week 30 changes in A1C values from baseline were −0.77 ± 0.08% (10-μg arm; adjusted P < 0.0001 vs. placebo), −0.55 ± 0.07% (5-μg arm; adjusted P < 0.0001 vs. placebo), and +0.23 ± 0.07% (placebo arm). C: Week 30 change in A1C stratified by baseline A1C. For subjects with baseline A1C <9%, baseline A1C values were 7.92 ± 0.04% (n = 169), 7.91 ± 0.04% (n = 172), and 7.94 ± 0.04% (n = 172) for the 10-μg exenatide, 5-μg exenatide, and placebo arms, respectively. The corresponding values for subjects with baseline A1C ≥9% were 9.86 ± 0.07% (n = 72), 9.75 ± 0.07% (n = 73), and 9.75 ± 0.07% (n = 75). D: Effects of exenatide on body weight. Subjects in the 10-μg exenatide b.i.d. treatment arm received 5 μg exenatide b.i.d. during weeks 0–4. Subjects in all treatment arms were maintained on metformin-sulfonylurea therapy. *P ≤ 0.001 compared with placebo treatment. Data are means ± SE.

Postprandial plasma glucose concentrations in the meal tolerance test subpopulation. A: Postprandial plasma glucose concentrations after a standardized meal at day 1. Subjects in all treatment arms received placebo. Postprandial plasma glucose geometric mean AUC_{(15–180 min)} values were 2,033 mmol · min · l⁻¹ in the 10-μg exenatide arm, 2,089 mmol · min · l⁻¹ in the 5-μg exenatide arm, and 2,090 mmol · min · l⁻¹ in the placebo arm. B: Postprandial plasma glucose concentrations after a standardized meal at week 30. Geometric mean AUC_{(15–180 min)} values were 1,539 mmol · min · l⁻¹ in the 10-μg exenatide arm (P = 0.0004 vs. placebo), 1,584 mmol · min · l⁻¹ in the 5-μg exenatide arm (P = 0.0009 vs. placebo), and 2,087 mmol · min · l⁻¹ in the placebo arm. Exenatide or placebo were administered at time zero. Evaluable population: 10 μg exenatide, n = 27; 5 μg exenatide, n = 27; placebo, n = 23. Subjects in the 10-μg exenatide b.i.d. arm received 5 μg exenatide b.i.d. during weeks 0–4. Subjects in all treatment arms were maintained on metformin-sulfonylurea therapy. Data are means ± SE.