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Pediatrics No pharmacokinetic data from studies of pediatric patients are currently available. Gender Text Continues Below
Metformin pharmacokinetic parameters did not differ significantly between normal subjects and patients with type 2 diabetes when analyzed according to gender (males = 19, females = 16). Similarly, in controlled clinical studies in patients with type 2 diabetes, the antihyperglycemic effect of GLUCOPHAGE (metformin hydrochloride tablets) was comparable in males and females. Race No studies of metformin pharmacokinetic parameters according to race have been performed. In controlled clinical studies of GLUCOPHAGE in patients with type 2 diabetes, the antihyperglycemic effect was comparable in whites (n= 249), blacks (n= 51), and Hispanics (n= 24). CLINICAL STUDIES GLUCOPHAGE In a double-blind, placebo-controlled, multicenter U. S. clinical trial involving obese patients with type 2 diabetes whose hyperglycemia was not adequately controlled with dietary management alone (baseline fasting plasma glucose [FPG] of approximately 240 mg/ dL), treatment with GLUCOPHAGE (up to 2550 mg/ day) for 29 weeks resulted in significant mean net reductions in fasting and postprandial plasma glucose (PPG) and hemoglobin A 1c (HbA 1c ) of 59 mg/ dL, 83 mg/ dL, and 1.8%, respectively, compared to the placebo group (see Table 2). *All patients on diet therapy at Baseline ** Not statistically significant H 3 C
H 3 C
NH 2 HCl N C C NH
NH NH Table 1. Select Mean (± S. D.) Metformin Pharmacokinetic Parameters Following Single or Multiple Oral Doses of GLUCOPHAGE
Subject Groups: GLUCOPHAGE C max b T max c Renal Clearance dose a (number of subjects) (µg/ mL) (hrs) (mL/ min)
Healthy, nondiabetic adults: 500 mg single dose (24) 1.03 (± 0.33) 2.75 (± 0.81) 600 (± 132)
850 mg single dose (74) d 1.60 (± 0.38) 2.64 (± 0.82) 552 (± 139)
850 mg three times daily for 2.01 (± 0.42) 1.79 (± 0.94) 642 (± 173)
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