Table 2.

Characteristics of Placebo-Controlled Trials of Pramlintide

			Study Sample at Baseline (Mean)
Author, Year, Quality	N	Duration, wk	Age, y Male, % White, %	Duration of Diabetes, y	HbA1C, % Weight, kg	Total Daily Insulin Dose Units	Pramlintide Dose and Titration Schedule
Type 1 diabetes
Whitehouse et al, 2002,10 Fair-poor	480	52	40.3 55.0 94.0	16.8	8.8 75.3	NR	30 μg tid-qid before meals + flexible-dose insulin. If HbA1c level decreased by <1%, patients were re-randomized to 30 μg or 60 μg. If change in HbA1C level was ≥1%, patients continued with 30 μg
Edelman et al, 2006,5 Fair	296	29	41.0 45.1 88.7	20.0	8.2 80.0	MDI: 65.1 CSII: 47.8	15 μg and titrated to 60 μg tid-qid before meals + flexible-dose insulin. Patients unable to tolerate maintenance dose had dose lowered to 30 μg or 15 μg. A 30%-50% reduction in prandial insulin was allowed
Ratner et al, 2004,7 Fair-poor	651	52	40.5 50.0 90.5	18.7	9.0 77.1	NR	60 μg tid-qid or 90 μg tid before meals + fixed-dose insulin. If nausea occurred within 2 wk of study, dose could be lowered by up to 50% for up to 2 wk
Type 2 diabetes
Riddle et al, 20079 Fair	212	16	55.0 48.8 72.5	12.2	8.5 103.0	51.0	60 μg and titrated to 120 μg bid-tid before meals + flexible-dose glargine ± metformin, sulfonylurea, and/or thiazolidinedione
Ratner et al, 20028 Fair-poor	538	52	56.5 59.0 78.5	12.3	9.2 NR	57.9	30 μg, 75 μg, or 150 μg tid before meals + fixed-dose insulin and/or metformin, sulfonylurea
Hollander et al, 20036 Fair	656	52	56.7 50.0 75.0	12.2	9.2 96.9	NR	60 μg tid, 90 μg bid, or 120 μg bid before meals + fixed-dose insulin and/or metformin, sulfonylurea. 60-μg dose study arm was excluded from efficacy analyses

bid = 2 times daily; CSII = continuous subcutaneous insulin infusion; HbA_1c = glycated hemoglobin; MDI = multiple daily injections; NR = not reported; qid = 4 times daily; tid = 3 times daily.