Table 6.
Severe Hypoglycemic Events in Placebo-Controlled Trials of Pramlintide in Type 1 Diabetes
|
Events per Patient-YearaMean No. (SE) |
|||
|---|---|---|---|
| Trial | Weeks 0–4 | Weeks 0–29 | Weeks 26–52 |
| Edelman et al, 20065 | |||
| Pramlintide, 30 μg tid-qid | 0.79 (0.46) | 1.10 (0.25) | – |
| Pramlintide, 60 μg tid- qid | 0.46 (0.46) | 0.42 (0.09) | – |
| Placebo | 0.42 (0.19) | 0.30 (0.06) | – |
| Whitehouse et al, 200210 | |||
| Pramlintide, 30 or 60 μg tid-qid | 2.12 (0.35) | – | 0.43 (0.07) |
| Placebo | 1.04 (0.24)b | – | 0.52 (0.08)b |
| Ratner et al, 20047 | |||
| Pramlintide, 60 μg tid | 3.78 (0.57) | – | 0.74 (0.12) |
| Pramlintide, 60 μg qid | 3.41 (0.55) | – | 0.79 (0.12) |
| Pramlintide, 90 μg tid | 3.91 (0.58) | – | 0.64 (0.12) |
| Placebo | 0.87 (0.27) | – | 0.45 (0.09) |
qid = 4 times daily; SE = standard error; tid = 3 times daily.
aEvent rates were calculated as the total number of events for all patients on a treatment regimen divided by the total number of patient-years of observation.
bEvent rates were calculated after excluding 1 patient in the placebo group who reported >100 episodes of severe hypoglycemia.