A multi-center study on clinical efficacy and safety of insulin enteric-coated soft capsules in patients with type 2 diabetes mellitus / 中华临床营养杂志

ABSTRACT

Objective To evaluate the clinical efficacy and safety of insulin enteric-coated soft capsules in patients with type 2 diabetes mellitus. Methods Totally 260 patients were enrolled in this multi-center,randomized, open, parallel-controlled clinical trial. Patients were orally administered with the capsule (capsule group, n = 135) or subcutaneously injected with insulin (control group, n = 125)one hour before the breakfast and supper time for 12 weeks. Results In the capsule group, the glyeosylated hemoglobin A1 c (HbA1 c)and fasting/postprandial blood glucoses were significantly decreased. In terms of the proportions of subjects achieving HbA1c goals using American Diabetes Association standard (HbA1c ≤7.0%)and International Diabetes Federation standard (HbA1c≤6.5%), they were 38.9% and 21.4% in capsule group and were 45.1% and 30. 2% in control group (P = 0. 323; P = 0. 109). The incidences of adverse reactions were not significantly different between these two groups (P = 0. 618). The satisfaction score was significantly higher in capsule group than in control group (P = 0. 000). Conclusion The insulin enteric-coated soft capsule has similar effectiveness and safety with insulin injections, and meanwhile is more popular among subjects.