2.14
Difference from
Glipizide -0.38a -0.37a
Difference from
Metformin -0.70a -0.69a
% Patients with Final
HbA1c <7% 43.5% 35.1% 59.6% 57.1%
Fasting Plasma
Glucose (mg/dL) N=169 N=176 N=170 N=169
Baseline Mean 210.7 207.4 206.8 203.1
Final Mean 162.1 163.8 152.1 148.7
Adjusted Mean Change
from Baseline -46.2 -42.9 -54.2 -56.5
Difference from
Glipizide -8.0 -10.4
Difference from
Metformin -11.3 -13.6
Table 3: Glipizide and Metformin HCl Tablets in Patients with Inadequate Glycemic Control on Sulfonylurea Alone: Summary of Trial Data at 18 Weeks Glipizide Metformin Glipizide and
5 mg 500 mg Metformin HCl
tablets tablets 5 mg/500mg tablets
a p<0.001
Mean Final Dose 30.0 mg 1927 mg 17.5 mg/
1747 mg
Hemoglobin A 1c (%) N=79 N=71 N=80
Baseline Mean 8.87 8.61 8.66
Final Adjusted Mean 8.45 8.36 7.39
Difference from Glipizide -1.06a
Difference from Metformin -0.98a
% Patients with Final HbA1c <7% 8.9% 9.9% 36.3%
Fasting Plasma Glucose (mg/dL) N=82 N=75 N=81
Baseline Mean 203.6 191.3 194.3
Adjusted Mean Change from
Baseline 7.0 6.7 -30.4
Difference from Glipizide -37.4
Difference from Metformin -37.2
Glipizide and Metformin HCl Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Glipizide and Metformin HCl Tablets is contraindicated in patients with :
Glipizide and Metformin HCl Tablets 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.)
Metformin Hydrochloride
Lactic acidosis:
Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Glipizide and Metformin HCl Tablets; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 μg/mL are generally found.
The reported incidence of lactic acidosis in patients receiving Metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal
hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications.
Patients with congestive heart failure requiring pharmacologic management, in pa
