Table 3.

Studies of pramlintide use in patients with type 2 DM

Study	Pat (n)	Study design	Duration (weeks)	Pramlintide dose	ΔHbA1c (%)	ΔWeight (kg)
(Thompson et al 1998)	203	MC, R, DB, PC	4	Placebo	−0.27	−0.04
				30 μg qid	−0.53*	−0.36
				60 μg tid	−0.58*	−0.89**
				60 μg qid	−0.51*	−0.72**
(Gottlieb et al 2007)	499	MC, DB, PC	26	Placebo	−0.1	0.1
				90 μg bid	−0.3	−0.8
				90 μg tid	−0.4	−1.3
				120 μg bid	−0.4*	−1.4
(Ratner et al 2005)	538	MC, R, DB, PC	52	Placebo	−0.2c	1.0c
				30 μg tid	−0.3c	−0.3c
				75 μg tid	−0.5c	−0.4*c
				150 μg td	−0.6*,c	−1.2*c
(Hollander et al 2003b)a	656	MC, R, DB, PC	52	Placebo	−0.25c	+0.7
				60 μg tid	− b	−b
				90 μg bid	−0.35	−0.5
				120 μg bid	−0.62*	−1.4*
(Hollander et al 2004)	498	Post hoc analysis of 2 RCTd	26	Placebo 120 μg bid	−0.41***	−1.8***

^aSubset of this population with lower HbA1c values also published (Hollander et al 2003a).

^bExcluded after efficacy analyses after results from another study (not identified) indicated that this dose was less effective.

^cThese data were extrapolated from graphs, because the absolute values were not reported in the test of the published studies.

^dGottlieb et al (1999), Hollander et al (2004).

^*p < 0.05;

^**p < 0.01;

^***p < 0.0001.

Abbreviations: DB, double-blind; MC, multicenter; PC, placebo-controlled; R, randomized; RCT, randomized control trials.