Glucovance

[Glyburide/Metformin]

Placebo Glyburide Metformin GLUCOVANCE GLUCOVANCE 2.5 mg 500 mg 1.25 mg/ 250 mg 2.5 mg/ 500 mg
tablets tablets tablets tablets
Mean Final Dose 0 mg 5.3 mg 1317 mg 2.78 mg/ 557 mg 4.1 mg/ 824 mg
Hemoglobin A 1c N= 147 N= 142 N= 141 N= 149 N= 152
Baseline Mean (%) 8.14 8.14 8.23 8.22 8.20
Mean Change from Baseline -0.21 -1.24 -1.03 -1.48 -1.53

Difference from Placebo -1.02 -0.82 -1.26 a -1.31 a
Difference from Glyburide -0.24 b -0.29 b
Difference from Metformin -0.44 b -0.49 b
Fasting Plasma Glucose N= 159 N= 158 N= 156 N= 153 N= 154
Baseline Mean FPG (mg/ dL) 177.2 178.9 175.1 178 176.6
Mean Change from Baseline 4.6 -35.7 -21.2 -41.5 -40.1
Difference from Placebo -40.3 -25.8 -46.1 a -44.7 a
Difference from Glyburide -5.8 c -4.5 c
Difference from Metformin -20.3 c -18.9 c
Body Weight Mean Change -0.7 kg +1.7 kg -0.6 kg +1.4 kg +1.9 kg
from Baseline
Final HbA 1c Distribution (%) N= 147 N= 142 N= 141 N= 149 N= 152

<7% 19.7% 59.9% 50.4% 66.4% 71.7%
7% and <8% 37.4% 26.1% 29.8% 25.5% 19.1%
8% 42.9% 14.1% 19.9% 8.1% 9.2%

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Table 4. Effects of Adding Rosiglitazone or Placebo in Patients Treated with GLUCOVANCE in a 24-Week Trial
Placebo Rosiglitazone ++
GLUCOVANCE GLUCOVANCE
Mean Final Dose GLUCOVANCE 10 mg/ 1992 mg 9.6 mg/ 1914 mg

rosiglitazone 0 mg 7.4 mg
Hemoglobin A 1c N= 178 N= 177
Baseline Mean (%) 8.09 8.14
Final Mean 8.21 7.23
Difference from Placebo a -1.02 b
Fasting Plasma Glucose N= 181 N= 176
Baseline Mean (mg/ dL) 173.1 178.4
Final Mean 181.4 136.3
Difference from Placebo a -48.5 b
Body Weight Mean Change from Baseline +0.03 kg +3.03 kg

Final HbA 1c Distribution (%) N= 178 N= 177
<7% 13.5% 42.4%
7% and <8% 32.0% 38.4%
8% 54.5% 19.2%

OVERDOSAGE

Glyburide

Overdosage of sulfonylureas, including glyburide tablets, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological findings, should be treated aggressively with oral glucose and adjustments in drug dosage and/ or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization.

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