Combination therapy of miglitol and insulin in type 1 diabetes mellitus patients.

Abstract

Aims/Introduction: Patients with type 1 diabetes mellitus often show a precipitous postprandial rise in blood glucose that cannot be controlled, even by intensive insulin therapy. The combined use of an α-glucosidase inhibitor with insulin seems to be highly beneficial in such cases. We investigated the efficacy and safety of miglitol, an α-glucosidase inhibitor, for 12 weeks in 43 type 1 diabetes patients on intensive insulin therapy. Co-administration of miglitol resulted in only a modest and temporal decrease in HbA1c level. However, it resulted in a significant reduction of plasma glucose level after breakfast (250.7 ± 102.0 mg/dL at 2 h after breakfast before treatment; 212.0 ± 95.8 mg/dL at 2 h after breakfast after treatment for 12 weeks, P = 0.01) and a significant reduction of insulin dosage (41.6 ± 17.1 U/day before treatment; 39.8 ± 17.4 U/day 12 weeks after treatment, P < 0.001). During the study period, 88.4% (38/43) of subjects experienced hypoglycemia, but all events were mild except for one case, which was considered to be moderate. No unexpected adverse events were observed during the study period. Co-administration of miglitol in type 1 diabetes patients on intensive insulin therapy resulted in an improvement of postprandial hyperglycemia with the reduction of insulin dosage. Considering the importance of postprandial hyperglycemia in the onset of cardiovascular disease, the combination therapy of miglitol and insulin could be advantageous in type 1 diabetes mellitus patients.