Alpha-glucosidase inhibitor Miglitol lowers A1c, postprandial glucose and insulin as monotherapy. Patients with type 2 diabetes who are treated by diet alone achieve significant reductions in hemoglobin A1c (HbA1c), postprandial glucose and insulin when treated with miglitol therapy.
A clinical trial conducted by M. L. Drent and colleagues at the VU Medical Center, in Amsterdam, The Netherlands, suggests that the optimal dose of the or most patients would be between 50 and 100 mg, three times a day.
The double-blind, placebo-controlled study, involved 468 patients with type 2 diabetes treated only by diet. Patients were randomly divided into a placebo group and four treatment groups receiving 25 mg, 50 mg, 100 mg, or 200 mg of miglitol three times a day.
After 24 weeks of treatment, the mean HbA1c level in the placebo group increased by 0.40 percent compared with baseline values. However, it significantly decreased in all miglitol groups in a dose-dependent manner — by 0.46 percent, 0.45 percent, 0.84 percent, and 1.26 percent, respectively, the researchers reported.
Similarly, mean blood glucose levels of patients in the placebo group at 12 and 24 weeks of treatment was 4 percent higher than at baseline, while they declined significantly for patients in all four miglitol groups — by 7 percent, 14 percent, 24 percent, and 33 percent, respectively.
Adverse events with miglitol were mainly gastrointestinal, mostly flatulence, diarrhoea and abdominal pain. Although not serious, the side effects were troublesome and led to a considerable dropout rate that increased with dosage.
"The alpha-glucosidase inhibitor miglitol in type 2 diabetic patients on diet alone decreases both HbA1c levels and postprandial glucose and insulin levels in a dose-dependent manner," the researchers conclude. "Gastrointestinal side effects also showed dose-dependency. Combination of efficacy and safety results leads to the conclusion that the optimal dose of miglitol will be in the range of 50 to 100 mg t.i.d." Diabetes Nutr Metab 2002; 15:152-159