Table 1.

Clinical trials of pramlintide

Author (year)	N	Design	Duration(weeks)	With meal doses added to insulin	Change from baseline in:
					1 h PPG (mmol/L) vs placebo	2 h PPG (mmol/L) vs placebo	A1C (%)	Weight (kg)
Type 1 studies
(Nyholm et al 1999)	14	DB, CO	4	30 μg qid	−7a	−4a
(Weyer et al 2003)	19	R, SB, CO	4	60 μg
				+regular insulin	−6a	−3.75a
				+lispro	−5a	−4.75a
(Levetan et al 2003)	18		4	30 μg qid	−4.4a	−3.6a
(Fineman et al 1999)	586	DB,	26	placebo			+0.1	+0.3
		MC		60 μg tid			−0.2b	−1.6
				90 μg bid			−0.1	−0.7
				90 μg tid			−0.1	−1.6
(Whitehouse et al 2002)	480	R, DB, MC	52	placebo			−0.16	+1a
				30–60 μg qid			−0.42b	−0.5a
(Ratner et al 2004)	538	R, DB, MC	52	placebo			−0.04	+0.8
				60 μg tid			−0.29b	−0.5b
				60 μg qid			−0.34b	−0.5b
(Edelman et al 2006)	296	R, DB	29	Placebo			−0.5	1.2
				30–60 μg tid			−0.5	−1.3
Type 2 studies
(Thompson et al 1998)	203	R, DB, MC	4	placebo			−0.27	−0.04
				30 μg qid			−0.53b	−0.36
				60 μg tid			−0.58b	−0.89b
				60 μg qid			−0.51b	−0.72b
(Maggs et al 2004)	19	R, SB, CO	single dose	120 μg	−4.75a	−3.4a
(Gottlieb 1999)	499	DB, MC	26	placebo			−0.1	+0.1
				90 μg bid			−0.3	−0.8
				90 μg tid			−0.4	−1.3
				120 μg bid			−0.4b	−1.4
(Ratner et al 2002)	538	R, DB, MC	52	placebo			−0.2a	1.0a
				30 μg tid			−0.3a	−0.3a
				75 μg tid			−0.5a	−0.4ab
				150 μg tid			−0.6b	−1.2ab
(Hollander et al 2003b)	498c	R, DB, MC	52	placebo			−0.22a	+0.5a
				90 μg bid			−0.35	−0.5
				120 μg bid			−0.62b	−1.4b
(Riddle et al 2007)	212	DB, PC	16	placebo		−1.9	−0.36	0.7
				60–12 μg bid-tid		−3.1	−0.70a	−1.6

^aThese data were extrapolated from graphs as the absolute values were not listed in the text of the published study.

^bp < 0.05.

^cThe study initially included a 60 mcg tid group (N = 158), but this group was not included in the analysis so the original N = 656.

Abbreviations: R, randomized; DB, double blind; MC, multi-center; PPG, postprandial glucose; SB, single blind; CO, crossover.