nge ± 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)
* - Glyburide was administered as 10 mg at breakfast and 5 mg at dinner.
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 ± 1.05 0.08 ± 1.05 -0.03 ± 1.05 0.71 ± 1.04
Mean Difference ± SE from Glyburide Alone -0.43 ± 0.52 -0.63 ± 0.53 -0.74 ± 0.52 N/A
95% CI for Difference (-1.46, 0.60) (-1.67, 0.40) (-1.77, 0.28)
p-value for pairwise comparison 0.410 0.230 0.156
INDICATIONS AND USE
GLUMETZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
CONTRAINDICATIONS
GLUMETZA is contraindicated in patients with:
GLUMETZA should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also PRECAUTIONS )
WARNINGS
Lactic Acidosis:
Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with GLUMETZA; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysi
