Glipizide and Metformin Hydrochloride (Page 4 of 10)

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 (e.g., glyburide 10 mg, glipizide 20 mg) were randomized to receive glipizide (fixed dose, 30 mg), metformin (500 mg), or glipizide and metformin hydrochloride tablets 5 mg/500 mg. The doses of metformin and glipizide and metformin hydrochloride 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 Hydrochloride Tablets as Second-Line Therapy: Summary of Trial Data at 18 Weeks
Glipizide Tablets 5 mg Metformin Tablets 500 mg Glipizide and Metformin Hydrochloride Tablets 5 mg / 500 mg
*
p <0.001
Mean Final Dose 30.0 mg 1927 mg 17.5 mg/1747 mg
Hemoglobin A1 c (%) N = 79 N = 71 N = 80
Baseline Mean 8.87 8.61 8.66
Final Adjusted Mean 8.45 8.36 7.39
Different from Glipizide -1.06*
Different from Metformin -0.98*
% Patients with Final HbA1 c <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
Different from Metformin -37.2

After 18 weeks, treatment with glipizide and metformin hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride tablets therapy and either metformin therapy or glipizide therapy. The adjusted mean changes from baseline in body weight were: glipizide and metformin hydrochloride 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 hydrochloride tablets.

INDICATIONS AND USAGE

Glipizide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

CONTRAINDICATIONS

Glipizide and metformin hydrochloride tablets are contraindicated in patients with:

  1. Severe renal impairment (eGFR below 30 mlL/min/1.73 m2)
  2. Known hypersensitivity to glipizide or metformin hydrochloride.
  3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

WARNINGS

Metformin Hydrochloride:

WARNING: LACTIC ACIDOSIS

Post-marketing cases of metformin-associated lactic acidosis have resulted in death,hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally > 5 mcg/mL [see PRECAUTIONS] Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see PRECAUTIONS].

If metformin-associated lactic acidosis is suspected, immediately discontinue glipizide and metformin hydrochloride and institute general supportive measures in a hospital setting.

Prompt hemodialysis is recommended [see PRECAUTIONS].

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