Hepatic impairment
Miglitol pharmacokinetics were not altered in cirrhotic patients relative to healthy control subjects. Since miglitol is not metabolized, no influence of hepatic function on the kinetics of miglitol is expected.

Gender
No significant difference in the pharmacokinetics of miglitol was observed between elderly men and women when body weight was taken into account.

Race
Several pharmacokinetic studies were conducted in Japanese volunteers, with results similar to those observed in Caucasians. A study comparing the pharmacodynamic response to a single 50-mg dose in Black and Caucasian healthy volunteers indicated similar glucose and insulin responses in both populations.

CLINICAL STUDIES
Clinical Experience in Non-Insulin-Dependent Diabetes Mellitus (NIDDM) Patients on Dietary Treatment Only
GLYSET Tablets were eva luated in two U.S. and three non-U.S. controlled, fixed-dose, monotherapy studies, in which 735 patients treated with GLYSET were eva luated for efficacy analyses (see Table 1).

In Study 1, a one-year study in which GLYSET was eva luated as monotherapy and also as combination therapy, there was a statistically significantly smaller increase in mean glycosylated hemoglobin (HbA1c) over time in the miglitol 50 mg 3 times daily monotherapy arm compared to placebo. Significant reductions in mean fasting and postprandial plasma glucose levels and in mean postprandial insulin levels were observed in patients treated with GLYSET compared with the placebo group.

In Study 2, a 14-week study, there was a significant decrease in HbA1c in patients receiving GLYSET 50 mg 3 times daily or 100 mg 3 times daily compared to placebo. In addition, there were significant reductions in postprandial plasma glucose and postprandial serum insulin levels compared to placebo.

Study 3 was a 6-month dose-ranging trial eva luating GLYSET at doses from 25 mg 3 times daily to 200 mg 3 times daily. GLYSET produced a greater reduction in HbA1c than placebo at all doses, although the effect was statistically significant only at the 100 mg 3 times daily and 200 mg 3 times daily doses. In addition, all doses of GLYSET produced significant reductions in postprandial plasma glucose and postprandial insulin levels compared to placebo.

Studies 4 and 5 were 6-month studies eva luating GLYSET at 50 and 100 mg 3 times daily, and 100 mg 3 times daily, respectively. As compared to placebo, GLYSET produced significant reductions in HbA1c, as well as a significant reduction in postprandial plasma glucose in both studies at the doses employed.

Table 1 Results of Monotherapy Study with GLYSET   HbA1c
(%) 1-hour
Postprandial Glucose
(mg/dL)
Study Treatment Mean Change from Baseline* Treatment Effect† Mean Change from Baseline Treatment Effect†
*
Mean baseline ranged from 7.54 to 8.72% in these s