Table 1

Baseline characteristics of the intent to treat study population

Variable Placebo (n=46) ABT-229 1.25 mg bid (n=52) ABT-229 2.5 mg bid (n=57) ABT-229 5 mg bid (n=52) ABT-229 10 mg bid (n=54)
Age (y) (mean (SD))45.0  (13.4)45.6  (13.7)43.3  (10.4)44.0  (12.3)45.9  (12.0)
Age at first diagnosis of diabetes (y) (mean (SD))23.4 (13.5)24.3 (14.5)21.5 (12.0)21.8 (14.2)23.6 (13.6)
Female (%)6567656269
Body mass index (mean (SD))27.0 (4.9)26.3 (5.2)26.0 (5.9)27.4 (6.2)28.7 (7.3)
Cisapride use previous 2 years (%)5051504040
Good/excellent response to cisapride previous 2 years (5)2522243414
Metoclopramide use previous 2 years (%)2520282620
Good/excellent response to metoclopramide previous 2 years (%)17025210
Caucasian (%)9190918587
Peripheral neuropathy1-1 (%)6556605659
Autonomic neuropathy1-1 (%)17823296
Renal insufficiency1-1 (%)17127106
Retinopathy1-1 (%)4837494639
Delayed gastric emptying (%)23.928.831.628.831.5
Upper abdominal discomfort severity score (mm) (model based mean (SD))387.8 (130.5)378.4 (133.4)375.9 (136.5)362.3 (125.5)376.3 (135.6)
Average sum of symptom severity score (diary) (mean SD))8.7 (3.4)8.1 (3.8)7.8 (4.4)8.1 (3.8)8.4 (3.8)
  • 1-1 Data based on investigator's statement that the condition was present and associated with diabetes.