Incidence of severe hypoglycemia and treatment-emergent adverse events with an incidence ≥10% and the incidence in one of the pramlintide groups at least double that of the placebo group (ITT population)
| . | Placebo TID . | Pramlintide 90 μg BID . | Pramlintide 120 μg BID . |
|---|---|---|---|
| Severe hypoglycemia* | |||
| 0–52 weeks | 0.3 ± 0.05 | 0.1 ± 0.03 | 0.3 ± 0.05 |
| 0–4 weeks | 0.3 ± 0.20 | 0.1 ± 0.08 | 0.9 ± 0.30 |
| 4–26 weeks | 0.3 ± 0.07 | 0.2 ± 0.06 | 0.4 ± 0.09 |
| 26–52 weeks | 0.2 ± 0.06 | 0.0 ± 0.02 | 0.1 ± 0.05 |
| Nausea (%)† | |||
| 0–52 weeks | 14 (1) | 31 (4) | 30 (2) |
| 0–4 weeks | 3 (0) | 18 (2) | 16 (2) |
| 4–26 weeks | 5 (1) | 5 (2) | 8 (0) |
| 26–52 weeks | 4 (0) | 3 (0) | 3 (0) |
| Headache (%)† | 8 (0) | 15 (1) | 17 (1) |
| . | Placebo TID . | Pramlintide 90 μg BID . | Pramlintide 120 μg BID . |
|---|---|---|---|
| Severe hypoglycemia* | |||
| 0–52 weeks | 0.3 ± 0.05 | 0.1 ± 0.03 | 0.3 ± 0.05 |
| 0–4 weeks | 0.3 ± 0.20 | 0.1 ± 0.08 | 0.9 ± 0.30 |
| 4–26 weeks | 0.3 ± 0.07 | 0.2 ± 0.06 | 0.4 ± 0.09 |
| 26–52 weeks | 0.2 ± 0.06 | 0.0 ± 0.02 | 0.1 ± 0.05 |
| Nausea (%)† | |||
| 0–52 weeks | 14 (1) | 31 (4) | 30 (2) |
| 0–4 weeks | 3 (0) | 18 (2) | 16 (2) |
| 4–26 weeks | 5 (1) | 5 (2) | 8 (0) |
| 26–52 weeks | 4 (0) | 3 (0) | 3 (0) |
| Headache (%)† | 8 (0) | 15 (1) | 17 (1) |
Event rate per patient year (total number of events for all patients in a given treatment regimen/total number of patient years of observation for all patients in that treatment regimen). Values are mean ± standard deviation.
Non-severe (severe) as defined in research design and methods.