Outcomes of Placebo-Controlled Trials of Pramlintide in Type 1 Diabetes
Trial, Duration | Change in HbA1cLevel % (95% CI) | PValue | Change in PPG, mg/dL | PValue | Change in Weight, kg | PValue |
---|---|---|---|---|---|---|
HbA1c=glycated hemoglobin; CI=confidence interval; NR = not reported; PPG = postprandial glucose; qid = 4 times daily; tid = 3 times daily. | ||||||
aChange from baseline to 3 hours postprandial. | ||||||
bCompared with placebo. | ||||||
Edelman et al, 2006,5 29 wk | ||||||
Pramlintide, 30 or 60 μg tidqid | 0.50 (−0.61 to −0.33) | – | −34a | NR | −1.3 | <.001b |
Placebo | −0.50 (−0.63 to −0.35) | – | −18a | NR | 1.2 | |
Whitehouse et al, 2002,10 52 wk | ||||||
Pramlintide, 30 or 60 μg qid | −0.39 | .007b | NR | – | −0.5 | NR |
Placebo | −0.12 | NR | – | +1.0 | NR | |
Ratner et al, 2004,7 52 wk | ||||||
Pramlintide, 60 μg tid | −0.29 | .011b | NR | – | −0.4 | .027b |
Pramlintide, 60 μg qid | −0.34 | .001b | NR | – | −0.4 | .04b |
Placebo | −0.04 | NR | – | +0.8 |