Table 1 Phase 3 and 4 clinical trials with mealtime pramlintide as adjunct to insulin in patients with type 2 diabetes

Ratner et al., 2002 [13]

Type 2 diabetes^b requiring insulin^c; mean age 55.5 to 57.5 y between groups; baseline HbA1c 9.0 % to 9.3 % between groups^d (538)

52

Placebo

Pramlintide (30, 75, 150 mcg TID) or placebo

Insulin with or without SFU, metformin

Hollander et al., 2003 [12]

Type 2 diabetes^b requiring insulin^e; mean age 56.4 to 57.0 y between groups; baseline HbA1c 9.0 % to 9.3 % between groups^d (656)

52

Placebo

Pramlintide (60 mcg TID, 90 mcg BID, 120 mcg BID) or placebo

Insulin with or without SFU, metformin

AstraZeneca (data on file) [14]

Type 2 diabetes^b requiring insulin^e; mean age 57.8 y; HbA1c 9.3 % to 9.5 % between groups^d (499)

26

Placebo

Pramlintide (90 mcg BID, 120 mcg BID, 90 mcg TID) or placebo

Insulin with or without SFU, metformin

Riddle et al., 2007 [15]

Type 2 diabetes not controlled by insulin glargine^f; mean age 55 y; baseline HbA1c 8.5 %^g (211)

16

Placebo

Pramlintide (60 or 120 mcg BID/TID) versus placebo

Insulin glargine with or without metformin, SFU, TZD

Riddle et al., 2009 [16] (phase 1 only)

Type 2 diabetes; mean age 55 y and 54 y; baseline HbA1c 8.2 % and 8.3 %; insulin-naïve or used <50 U/d of basal insulin for <6 months^g (112)

24

Rapid-acting insulin

Pramlintide (60 or 120 mcg BID/TID) versus rapid-acting insulin

Insulin glargine or detemir with or without metformin, SFU, TZD