Miglitol veelbelovend voor inadequaat gecontroleerde DM2Nieuws - Nov. 10, 2010
Miglitol shows promise for inadequately controlled Type 2 diabetes
Trial findings suggest that miglitol could be a useful adjuvant therapy for Chinese patients with Type 2 diabetes that is inadequately controlled by diet and sulfonylurea treatment.
Miglitol is the first pseudomonosaccharide α-glucosidase inhibitor derived from 1-deoxynojirimycin and is structurally a glucose analogue, say Sheng-Hwu Hsieh (Chang Gung Memorial Hospital, Taoyuan) and colleagues.
The class of α-glucosidase inhibitors has a unique mode of action, they explain, which blocks oligosaccharide catabolism, delays carbohydrate digestion and absorption, and smoothes and lowers postprandial plasma glucose peaks.
The team examined the efficacy and tolerability of miglitol in improving glycemic control in a trial of 105 Chinese patients with Type 2 diabetes that was inadequately controlled by diet and sulfonylurea treatment. Participants were randomly assigned to receive 24 weeks of treatment with miglitol, consisting of 50 mg three times daily titrated to 100 mg in patients with good tolerance at the discretion of the investigator, or placebo.
Concomitant sulfonylurea treatment remained unchanged throughout the study and patients were asked to adhere to a dietary plan in accordance with American Diabetes Association recommendations.
The primary endpoint of the change in glycated hemoglobin levels from baseline to 24 weeks in the intention-to-treat population showed a mean decrease of 0.85% in the 49 patients treated with miglitol compared with 0.19% in the 51 receiving placebo, a statistically significant difference.
There was also a significant difference in the secondary endpoint of change in postprandial plasma glucose, with a mean decrease of 44.80 mg/dl in the miglitol group versus an increase of 14.07 mg/dl in the placebo group. However, there were no significant differences in fasting plasma glucose or postprandial serum insulin.
The most common adverse events were mild hypoglycemia, diarrhea, and abdominal discomfort, resulting in premature termination of miglitol treatment by four patients.
Approximately half the miglitol-treated patients versus 15.7% of placebo-treated patients experienced these symptoms, report the researchers in the journal Acta Diabetologica.
Nonetheless, they conclude: "Miglitol may be a useful adjuvant therapy for Chinese patients with Type 2 diabetes inadequately controlled by diet and sulfonylurea treatment."