There were no clinically meaningful differences in changes from baseline for all lipid parameters between Glipizide and Metformin HCl Tablets therapy and either metformin therapy or glipizide therapy. The adjusted mean changes from baseline in body weight were: Glipizide and Metformin HCl Tablets 2.5 mg/250 mg, -0.4 kg; Glipizide and Metformin HCl Tablets.2.5 mg/500 mg, -0.5 kg; glipizide, -0.2 kg; and metformin, -1.9 kg. Weight loss was greater with metformin than with Glipizide and Metformin HCl Tablets.

Patients with Inadequate Glycemic Control on Sulfonylurea Monotherapy

In an 18-week, double-blind, active-controlled U.S. clinical trial, a total of 247 patients with type 2 diabetes not adequately controlled (HbA1c ≥7.5% and ≤12% and FPG <300 mg/dL) while being treated with at least one-half the maximum labeled dose of a sulfonylurea (eg, glyburide 10 mg, glipizide 20 mg) were randomized to receive glipizide (fixed dose, 30 mg), metformin (500 mg), or Glipizide and Metformin HCl Tablets 5 mg/500 mg. The doses of metformin and Glipizide and Metformin HCl Tablets were titrated (up to the eight-week visit) to a maximum of four tablets daily as needed to achieve MDG ≤130 mg/dL. Trial data at 18 weeks are summarized in Table 3.

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 A1c (%) 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

After 18 weeks, treatment with Glipizide and Metformin HCl Tablets at doses up to 20 mg/2000 mg per day resulted in significantly lower mean final HbA1c and significantly greater mean reductions in FPG compared to glipizide and to metformin therapy. Treatment with Glipizide and Metformin HCl Tablets lowered the three-hour postprandial glucose AUC, compared to baseline, to a significantly greater extent than did the glipizide and the metformin therapies. Glipizide and Metformin HCl Tablets did not significantly affect fasting insulin levels.

There were no clinically meaningful differences in changes from baseline for all lipid parameters between Glipizide and Metformin HCl Tablets therapy and either metformin therapy or glipizide therapy. The adjusted mean changes from baseline in body weight were: Glipizide and Metformin HCl Tablets 5 mg/500 mg, -0.3 kg; glipizide, -0.4 kg; and metformin, -2.7 kg. Weight loss was greater with metformin than with Glipizide and Metformin HCl Tablets.

INDICATIONS AND USAGE
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.

CONTRAINDICATIONS
Glipizide and Metformin HCl Tablets is contraindicated in patients with :

Renal disease or renal dysfun