The clinical study to evaluate the safety and efficacy of D-chiro-inositol in patients with type 2 diabetes

Ku, Bon Jeong; Kim, Hyun Jin; Park, Kang Seo

Abstract

BACKGROUND: D-chiro-inositol (DCI) is a postreceptor signaling molecule of insulin action. Blood and urine levels of DCI were decreased in diabetic animals. Treatment of DCI improves insulin resistance and normalizes blood glucose level in diabetic animals. In diabetic patients, treatment of DCI has a effect of glucose control in some study but not in others. So we study to confirm the effect and to evaluate the safety of DCI by the use of pinitol, methyl derivates of DCI.
METHODS
We performed a randomized, double-blind, placebo-controlled study in 82 patients with type 2 diabetes mellitus who visited the Eulji University Hospital from March 2005 to August 2005. We checked the change of HbA1c, FBS, and PP2 to evaluate pinitol effect of sugar control. And also we checked the effect of pinitol treatment to evaluate safety.
RESULTS
We treated with either pinitol or placebo for 12 weeks in 66 patients and completed the study in 61 patients. There are no difference in the basal clinical or laboratory data between the pinotol and control groups. In the pinitol group there more decrease in the levels of HbA1c and in fasting blood glucose than in control group after 12 weeks study. When we performed subgroup analysis, in patients with a HbA1c level above 8% there was a more effectively respond to pinitol treatment. Than in less no significant side effects was occurred. There are no differences in side effects seen between the two groups.
CONCLUSIONS
Treatment of pinitol was effective and safe in type 2 diabetic patients who received oral hypoglycemic agents. This is especially seen in patients with a high HbA1c level (>8%).