Study disposition and demographic characteristics for the ITT population
| Disposition | Double-blind study | Open-label extension | ||||||
|---|---|---|---|---|---|---|---|---|
| Placebo | Pramlintide | Placebo* | Pramlintide* | |||||
| n | % | n | % | n | % | n | % | |
| ITT population | 237 | 243 | 111 | 125 | ||||
| Withdrawals | 69 | 29.1 | 69 | 28.4 | 38 | 34.2 | 37 | 29.6 |
| Adverse event | 19 | 8.0 | 31 | 12.8 | 18 | 16.2 | 8 | 6.4 |
| Noncompliance | 13 | 5.5 | 8 | 3.3 | — | — | — | — |
| Protocol violation | 6 | 2.5 | 1 | 0.4 | 0 | 0 | 5 | 4.0 |
| Withdrawal of consent | 14 | 5.9 | 12 | 4.9 | 15 | 13.5 | 18 | 14.4 |
| Other | 17 | 7.2 | 17 | 7.0 | 5 | 4.5 | 6 | 4.8 |
| Evaluable population | 168 | 70.9 | 174 | 71.6 | 73 | 65.8 | 88 | 70.4 |
| Demographic Characteristics at Baseline | ||||||||
| Sex: male/female (%) | 55/45 | 55/45 | 56/44 | 59/41 | ||||
| Race: Caucasian/other (%) | 92/8 | 96/5† | 95/6† | 97/3 | ||||
| Age (years) | 40.4 ± 12.1 | 40.3 ± 11.6 | 44.7 ± 11.7 | 42.7 ± 10.8 | ||||
| Weight (kg) | 75.6 ± 13.3 | 75.0 ± 13.8 | 77.1 ± 13.7 | 76.0 ± 13.9 | ||||
| BMI (kg/m2) | 25.8 ± 3.5 | 25.2 ± 3.3 | 26.3 ± 3.4 | 25.4 ± 3.3 | ||||
| HbAlc (%) | 8.9 ± 1.5 | 8.7 ± 1.3 | 8.7 ± 1.3 | 8.3 ± 1.4 | ||||
| Duration of diabetes (years) | 17.1 ± 10.5 | 16.5 ± 10.0 | ||||||