Clinical Results

Two large studies undertaken by Bayer have shown that Glyset is particularly effective among Hispanic and African-American Type II patients. This is significant because Type II diabetes is more prevalent and is more commonly associated with complications in these subpopulations compared to Caucasian Type II patients.

Hispanics have a 300 percent higher chance of developing Type II diabetes than the general population and African-Americans are 60 percent more likely to develop Type II diabetes than Caucasians. Hispanic and African-American Type II patients have been typically under-represented in clinical trials of new diabetes therapies. The demonstration of Glyset’s efficacy and safety in these sub-populations confirm its importance as a therapeutic option for these patients.

In study 1, a one-year study in which Glyset 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 Glyset-treated patients 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.

Side Effects

Unlike sulfonylureas, another class of drugs to treat Type II diabetes, Glyset and Precose do not cause hypoglycemia, hyperinsulinemia or weight gain. If side effects occur with Glyset they usually develop during the first few weeks of therapy and are most commonly mild-to-moderate gastrointestinal effects, such as flatulence, soft stools or diarrhea, or abdominal pain. Many of these effects diminish in frequency and intensity over time. Studies have shown no evidence of serious side effects.

Glyset is contraindicated in patients with known hypersensitivity to the drug and in patients with diabetic ketoacidosis, inflammatory bowel disease, colonic ulceration or partial intestinal obstruction. Glyset is also contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine.

Mechanism of Action

In contrast to sulfonylureas, GLYSET does not enhance insulin secretion. The antihyperglycemic action of miglitol results from a reversible inhibition of membrane-bound intestinal a-glucosidases hydrolyze oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in delayed glucose absorption and lowering of poptprandial hyperglycemia.

Because its mechanism of action is different, the effect of Glyset to enhance glycemic control is additive to that of sulfonylureas when used in combination. In addition, GLYSET diminishes the insulinotropic and weight-increasing effects of sulfonylureas.

Miglitol has minor inhibitory activity against lactase and consequently, at the recommended doses, would not be expected to induce lactose intolerance.