Table 2.

Characteristics of Placebo-Controlled Trials of Pramlintide

Study Sample at Baseline (Mean)
Author, Year, QualityNDuration, wkAge, y
 Male, %
 White, %Duration of Diabetes, yHbA1C, % Weight, kgTotal Daily Insulin Dose UnitsPramlintide Dose and Titration Schedule
bid = 2 times daily; CSII = continuous subcutaneous insulin infusion; HbA1c = glycated hemoglobin; MDI = multiple daily injections; NR = not reported; qid = 4 times daily; tid = 3 times daily.
Type 1 diabetes
Whitehouse et al, 2002,10 Fair-poor4805240.3
 55.0
 94.016.88.8
 75.3NR30 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 Fair2962941.0
 45.1
 88.720.08.2
 80.0MDI: 65.1
 CSII: 47.815 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-poor6515240.5
 50.0
 90.518.79.0
 77.1NR60 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 Fair2121655.0
 48.8
 72.512.28.5
 103.051.060 μg and titrated to 120 μg bid-tid before meals + flexible-dose glargine ± metformin, sulfonylurea, and/or thiazolidinedione
Ratner et al, 20028 Fair-poor5385256.5
 59.0
 78.512.39.2
 NR57.930 μg, 75 μg, or 150 μg tid before meals + fixed-dose insulin and/or metformin, sulfonylurea
Hollander et al, 20036 Fair6565256.7
 50.0
 75.012.29.2
 96.9NR60 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