Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Endocrinology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved December 1996
Treatment Area: type II diabetes
Glyset has been approved for the treatment of Type II
(non-insulin-dependent) diabetes mellitus (NIDDM).
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
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.
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
Miglitol has minor inhibitory activity against lactase and
consequently, at the recommended doses, would not be expected to
induce lactose intolerance.