New clinical study shows patients with Type 2 diabetes may be able to tolerate higher doses of metformin using GLUMETZA….
Depomed, Inc., announced new data suggesting that patients previously intolerant of metformin may be able to tolerate higher doses of metformin when treated with GLUMETZA® (metformin HCl extended release tablets). The findings [abstract #0729-P] were presented at the ADA’s 70th Scientific Sessions in Orlando.
GLUMETZA is a once-daily, extended release formulation of metformin, and is approved for use in adults with Type 2 diabetes mellitus. “Clinical guidelines recommend using metformin as the first-line therapy for Type 2 diabetes. Although most patients should receive the maximum recommended daily dose of 2000 mg per day to achieve optimal glycemic control, they often cannot tolerate such dosages because of gastrointestinal (GI) side effects,” said Ralph A. DeFronzo, M.D., Professor of Medicine, Chief of the Diabetes Division, University of Texas Health Sciences Center, San Antonio, who co-authored the study. “These promising new results indicate that by using GLUMETZA, an extended-release formulation of metformin, physicians might be able to use higher doses of metformin while lowering patients’ risk of dose-limiting gastrointestinal events.”
In the four-week observational study, 87 patients with Type 2 diabetes with a history of inability to tolerate a dose of 1000 mg or more of metformin daily were treated with GLUMETZA. The primary endpoint of the study was comparison of the maximum tolerated dose of GLUMETZA compared to the maximum dose of the patient’s previous metformin formulation. Secondary endpoints included the proportion of patients able to tolerate a GLUMETZA dose greater than 1000 mg, and the number of patients experiencing at least one GI adverse event. The study results indicated that patients were able to use a higher mean maximum tolerated dose compared to the maximum dose of their previous metformin formulations (1477 mg vs. 1204 mg, respectively, p<0.001). Overall, 95.4% of patients treated with GLUMETZA tolerated at least 1000 mg daily; 43% of patients tolerated up to 2000 mg daily of GLUMETZA.
The number of patients with at least one GI adverse event (abdominal pain, diarrhea, GI upset, and nausea) was lower with GLUMETZA than with previous metformin formulations (38% vs. 88%, respectively). One patient discontinued GLUMETZA due to an adverse GI event.
GLUMETZA is contraindicated in patients with renal dysfunction, known hypersensitivity to metformin HCl or metabolic acidosis, including diabetic ketoacidosis. Use of concomitant medications that affect renal function or hemodynamic change may interfere with the disposition of metformin and should be used with caution.
Hypoglycemia does not occur in patients receiving GLUMETZA alone but could occur with deficient caloric intake or during concomitant use with other glucose-lowering agents or ethanol. Loss of glycemic control may occur when a stabilized patient is exposed to stress.
Depomed, Inc. Press Release