In a double-blind, randomized, placebo-controlled (glyburide add-on) multicenter study, patients with type2 diabetes mellitus who were newly diagnosed or treated with diet and exercise, or who were receiving monotherapy with metformin, sulfonylureas, alpha-glucosidase inhibitors, thiazolidinediones, or meglinitides, or treated with combination therapy consisting of metformin/glyburide at doses up to 1000mg metformin +10mg glyburide per day (or equivalent doses of glipizide or glimepiride up to half the maximum therapeutic dose) were enrolled. They were stabilized on glyburide for a 6-week period, and then randomized to 1 of 4treatments: placebo +glyburide (glyburide alone); GLUMETZA 1500mg once a day +glyburide, GLUMETZA 2000mg once a day +glyburide, or GLUMETZA 1000mg twice a day +glyburide. A 3-week GLUMETZA titration phase was followed by a 21-week maintenance treatment phase. The difference in the change from Baseline in HbA1c levels between the combined M-ER+SU (sulfonylurea) groups and the SU only group was statistically significant (p<0.001). The changes in glycemic control across the three GLUMETZA+glyburide groups were comparable. (SeeTable4)

Table 4: Mean±SE Changes from Baseline to Final Visit in HbA1c, Fasting Plasma Glucose and Body Weight for the GLUMETZA/Glyburide Groups and Placebo/Glyburide Treatment Group (Second 24-Week Study)  Parameter  GLUMETZA +Glyburide*  Placebo/
Glyburide*
(n =144) 
1500mg QD
(n =144)  1000mg BID
(n =141)  2000mg QD
(n =146) 
HbA1c (%)
n  136  136  144  141 
Baseline  7.93 ±0.13  7.75 ±0.13  7.68 ±0.13  8.08 ±0.13 
Mean Change ±SE at Final Visit  -0.72 ±0.09  -0.82 ±0.09  -0.71 ±0.08  -0.07 ±0.08 
Mean Difference ±SE from Glyburide Alone  -0.79 ±0.11  -0.89 ±0.11  -0.77 ±0.11  N/A 
95% CI for Difference  (-1.01, -0.57)  (-1.11, -0.67)  (-0.99, -0.56) 
 
p-value for pairwise comparison  < 0.001  < 0.001  < 0.001 
 
Fasting Plasma Glucose (mg/dL)
n  143  141  145  144 
Baseline  163.4 ±4.6  163.2 ±4.7  158.8 ±4.7  164.0 ±4.7 
Mean Change ±SE at Final Visit  -13.7 ±3.7  -15.7 ±3.7  -9.4 ±3.7  15.5 ±3.7 
Mean Difference ±SE from Glyburide Alone  -29.2 ±4.9  -31.2 ±40.9  -24.9 ±4.9  N/A 
95% CI for Difference  (-38.8, -19.6)  (-40.9, -21.6)  (-34.5, -15.4) 
 
p-value for pairwise comparison  < 0.001  < 0.001  < 0.001 
 
Body Weight (kg)
n  143  141  146  144 
Baseline  89.38 ±11.21  103.70 ±11.21  102.90 ±11.21  95.56 ±7.96 
Mean Change ±SE at Final Visit  0.28 &pl