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GLYSET (MIGLITOL): CLINICAL STUDIES
Clinical Experience in Non-Insulin-Dependent Diabetes Mellitus (NIDDM) Patients on Dietary Treatment Only
Glyset tablets were evaluated in two U.S. and three non-U.S. controlled, fixed-dose, monotherapy studies, in which 735 patients treated with GLYSET were evaluated for efficacy analyses.
In Study 1, a one-year study in which Glyset (Miglitol) was evaluated 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 Miglitol (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 evaluating Glyset (Miglitol) at doses from 25 mg 3 times daily to 200 mg 3 times daily. This drug 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 Miglitol (Glyset) produced significant reductions in postprandial plasma glucose and postprandial insulin levels compared to placebo.
Studies 4 and 5 were 6-month studies evaluating Glyset at 50 and 100 mg 3 times daily, and 100 mg 3 times daily, respectively. As compared to placebo, this medicine produced significant reductions in HbA1c, as well as a significant reduction in postprandial plasma glucose in both studies at the doses employed.
Clinical Experience in NIDDM Patients Receiving Sulfonylureas
Glyset was studied as adjunctive therapy to a background of maximal or near-maximal sulfonylurea (SFU) treatment in three large, double-blind, randomized studies (two U.S. and one non-U.S.) in which 471 patients treated with Glyset (Miglitol) were evaluated for efficacy.
Study 6 included patients under treatment with maximal doses of SFU at entry. At the end of this 14week study, the mean treatment effects on glycosylated hemoglobin (HbA1c) were -0.82% and -0.74% for patients receiving Miglitol (Glyset) 50 mg 3 times daily plus SFU, and Glyset 100 mg 3 times daily plus SFU, respectively.
Study 7 was a one-year study in which this medication at 25, 50 or 100 mg 3 times daily was added to a maximal dose of glyburide (10 mg twice daily). At the end of this study, the mean treatment effects on HbA1c of Glyset when added to maximum glyburide therapy were -0.30%, -0.62%, and -0.73% with the 25, 50 and 100 mg 3 times daily dosages of Glyset (Miglitol), respectively.
In Study 8, the addition of Miglitol (Glyset) 100 mg 3 times daily to a background of treatment with glyburide produced an additional mean treatment effect on HbA1c of -0.66%.
Results from controlled, fixed-dose studies of Glyset as monotherapy or as combination treatmentwith a sulfonylurea were combined to derive a pooled estimate of the difference from placebo in the mean change from baseline in glycosylated hemoglobin (HbA1c) and postprandial plasma glucose.
Because of its mechanism of action, the primary pharmacologic effect of miglitol is manifested as a reduction in postprandial plasma glucose, as shown previously in all of the major clinical trials. Glyset (Miglitol) was statistically significantly different from placebo at all doses in each of the individual studies with respect to effect on mean one-hour postprandial plasma glucose, and there is a dose response from 25 to 100 mg 3 times daily for this efficacy parameter.
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