A second double-blind, placebo-controlled study (n=51), with 16weeks of randomized treatment, demonstrated that in patients with type2 diabetes controlled on insulin for 8weeks with an average HbA1c of 7.46± 0.97%, the addition of metformin maintained similar glycemic control (HbA1c 7.15± 0.61 versus 6.97± 0.62 for metformin plus insulin and placebo plus insulin, respectively) with 19% less insulin versus baseline (reduction of 23.68± 30.22 versus an increase of 0.43± 25.20units for metformin plus insulin and placebo plus insulin, p<0.01). In addition, this study demonstrated that the combination of metformin plus insulin resulted in reduction in body weight of 3.11± 4.30lbs, compared to an increase of 1.30± 6.08lbs for placebo plus insulin, p=0.01.

16. HOW SUPPLIED/STORAGE AND HANDLING
GLUMETZA tablets- 500mg are available as blue, film coated, oval-shaped tablets debossed with "GMZ" on one side and "500" on the other side.

GLUMETZA tablets 1000mg are available as white, film coated, oval-shaped tablets with "M1000" on one side.

They are supplied as follows:

Package Strength NDC Code
Bottles of 100 500mg 13913-002-13
Bottles of 90 1000mg 13913-003-16

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F); see [USP Controlled Room Temperature].

17. PATIENT COUNSELING INFORMATION
Information for Patients

Patients should be informed of the potential risks and benefits of GLUMETZA and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, and hemoglobin A1c. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.
The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the GLUMETZA sections, should be explained to patients. Patients should be advised to discontinue GLUMETZA immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of GLUMETZA, gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to recur. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
Patients should be advised to notify their health practitioner or call the Poison Control Center immediately in case of GLUMETZA overdose.
Patients should be informed about the importance of regular testing of renal function and hematological parameters when receiving treatment with GLUMETZA.
Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving GLUMETZA.
GLUMETZA (metformin hydrochloride extended-release tablets) alone does not usually cause hypoglycemia, although it may occur when GLUMETZA is used in conjunction with insulin secretagogues, such as sulfonylureas and insulin.
Patients should be informed that GLUMETZA must be swallowed whole and not crushed or chewed, and that the inactive ingredients may occasio