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 (%) | 65 | 67 | 65 | 62 | 69 |
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 (%) | 50 | 51 | 50 | 40 | 40 |
Good/excellent response to cisapride previous 2 years (5) | 25 | 22 | 24 | 34 | 14 |
Metoclopramide use previous 2 years (%) | 25 | 20 | 28 | 26 | 20 |
Good/excellent response to metoclopramide previous 2 years (%) | 17 | 0 | 25 | 21 | 0 |
Caucasian (%) | 91 | 90 | 91 | 85 | 87 |
Peripheral neuropathy1-1 (%) | 65 | 56 | 60 | 56 | 59 |
Autonomic neuropathy1-1 (%) | 17 | 8 | 23 | 29 | 6 |
Renal insufficiency1-1 (%) | 17 | 12 | 7 | 10 | 6 |
Retinopathy1-1 (%) | 48 | 37 | 49 | 46 | 39 |
Delayed gastric emptying (%) | 23.9 | 28.8 | 31.6 | 28.8 | 31.5 |
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.