Table 3: Mean±SE Changes from Baseline to Final Visit in HbA1c, Fasting Plasma Glucose and Body Weight for the GLUMETZA and Metformin IR Treatment Groups (First 24-Week Study)  Parameter  GLUMETZA  Metformin IR
1500 mg AM/PM
(n = 174) 
1500 mg QD
(n = 178)  1500 mg AM/PM
(n = 182)  2000 mg QD
(n = 172) 
HbA1c (%) 
n  169  175  159  170 
Baseline  8.22 ± 0.25  8.50 ± 0.24  8.26 ± 0.24  8.70 ± 0.25 
Mean Change ± SE at Final Visit  -0.73 ± 0.12  -0.74 ± 0.12  -1.06 ± 0.12  -0.70 ± 0.12 
Mean Difference ± SE from Metformin IR  -0.03 ± 0.12  -0.04 ± 0.12  -0.36 ± 0.12  N/A 
98.4% CI for Difference  (-0.32, 0.26)  (-0.33, 0.25)  (-0.65, -0.06) 
 
Fasting Plasma Glucose (mg/dL) 
n  175  179  170  172 
Baseline  190.0 ± 9.9  192.5 ± 9.9  183.9 ± 9.9  196.5 ± 11.2 
Mean Change ± SE at Final Visit  -38.5 ± 4.4  -31.8 ± 4.4  -42.0 ± 4.5  -32.1 ± 4.5 
Mean Difference ± SE from Metformin IR  -6.4 ± 4.4  0.2 ± 4.3  -9.9 ± 4.4  N/A 
95% CI for Difference  (-15.0, 2.1)  (-8.3, 8.7)  (-18.5, -1.3) 
 
Body Weight (kg) 
n  176  180  171  173 
Baseline  88.17 ± 3.66  90.50 ± 3.66  87.73 ± 3.66  88.72 ± 3.87 
Mean Change ± SE at Final Visit  -0.93 ± 0.40  -0.68 ± 0.40  -1.10 ± 0.40  -0.85 ± 0.41 
Mean Difference ± SE from Metformin IR  -0.09 ± 0.40  0.17 ± 0.39  -0.26 ± 0.40  N/A 
95% CI for Difference  (-0.86, 0.69)  (-0.61, 0.94)  (-1.04, 0.52) 
 
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) 
1500 mg QD
(n = 144)  1000 mg BID
(n = 141)  2000 mg 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&nbs