Table Summary of efficacy results for exenatide in combination with basal insulin compared to placebo (ITT subjects) Least Squares Mean or Percentage of subjects Variable Exenatide Placebo Between Treatment Difference (95% CI) (N=137) (N=122) Primary Objective Haemoglobin (A1c%) Baseline 8.3 8.5 -0.20 Week 30 6.7 7.4 -0.71 (-0.95 to -0.47) Change -1.7 -1.0 p<0.001 Secondary Objectives Proportion reaching glycaemic target Haemoglobin A1c <7.0% 56% 29% -- Haemoglobin A1c ≤6.5% 42% 13% -- Body weight (kg) Baseline 95.4 93.8 1.6 Week 30 93.6 96.3 Change -1.78 +0.96 -2.74 (-3.74 to -1.74) Change in insulin dose at Week 30 U/day 13 20 -6.5 (-12.24 to -0.79) U/kg 0.15 0.20 -0.05 (-0.10 to 0.00) Fasting serum glucose (mmol/L) Baseline 7.4 7.4 -0.01 Week 30 6.1 6.5 Change -1.28 -0.87 -0.41 (-0.99 to 0.18) Change in glucose excursion (mmol/L) Morning 2-hour -2.0 -0.2 -1.8 (-2.5 to -1.2) Midday 2-hour -0.5 -0.3 -0.3 (-0.8 to 0.3) Evening 2-hour -1.6 0.1 -1.7 (-2.3 to -1.1) Abbreviations: CI=confidence interval. When exenatide was added to existing basal insulin therapy (insulin glargine), the dose of basal insulin was decreased by 20% in patients with an HbA1c per ≤8.0%,
Table Summary of efficacy results for exenatide in combination with basal insulin compared to placebo (ITT subjects) Least Squares Mean or Percentage of subjects Variable Exenatide (N=137) Placebo (N=122) Between Treatment Difference (95% CI) Primary Objective Haemoglobin (A1c%) Baseline Week 30 Change 8.3 6.7 -1.7 8.5 7.4 -1.0 -0.20 -0.71 (-0.95 to -0.47) p<0.001 Secondary Objectives Proportion reaching glycaemic target Haemoglobin A1c <7.0% Haemoglobin A1c ≤6.5% 56% 42% 29% 13% -- -- Body weight (kg) Baseline Week 30 Change 95.4 93.6 -1.78 93.8 96.3 +0.96 1.6 -2.74 (-3.74 to -1.74) Change in insulin dose at Week 30 U/day U/kg 13 0.15 20 0.20 -6.5 (-12.24 to -0.79) -0.05 (-0.10 to 0.00) Fasting serum glucose (mmol/L) Baseline Week 30 Change 7.4 6.1 -1.28 7.4 6.5 -0.87 -0.01 -0.41 (-0.99 to 0.18) Change in glucose excursion (mmol/L) Morning 2-hour Midday 2-hour Evening 2-hour -2.0 -0.5 -1.6 -0.2 -0.3 0.1 -1.8 (-2.5 to -1.2) -0.3 (-0.8 to 0.3) -1.7 (-2.3 to -1.1) Abbreviations: CI=confidence interval. When exenatide was added to existing basal insulin therapy (insulin glargine), the dose of basal insulin was decreased by 20% in patients with an HbA1c ≤8.0%, per
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