[Voglibose for the prevention of type 2 diabetes mellitus: a randomised, double-blind trial in Japanese subjects with impaired glucose tolerance].
The study to assess whether voglibose could prevent type 2 diabetes developing in high-risk Japanese subjects with impaired glucose tolerance (IGT) were performed. This was a multicenter, randomised, double-blind, parallel group trial comparing voglibose 0.2 mg three times a day and corresponding placebo. 1,780 eligible subjects received standard diet and exercise therapy, and 897 were randomised to receive voglibose and 883 placebo. The study was planned for treatment to be continued until participants developed type 2 diabetes[primary endpoint; determined by bi-annual oral glucose tolerance tests (OGTTs) as well as fasting blood glucose measured every 3 months] or normalisation of the OGTT or for a minimum of 3 years, subject to the findings of an interim analysis. The interim analysis significantly favoured voglibose and this end-of-study report involves individuals treated for an average of 48.1 weeks. Subjects treated with voglibose had a significantly lower risk for the progression to type 2 diabetes than placebo (50/897 vs 106/881: hazard ratio 0.595). Also, significantly more subjects in the voglibose group achieved a normal OGTT compared with those in the placebo group (599/897 vs 454/881: hazard ratio 1.539). Voglibose, in addition to standard care with diet and exercise, was effective in preventing the progression of IGT to type 2 diabetes and in facilitating the normalisation of the OGTT in high-risk Japanese subjects with IGT.
Kawamori
Ryuzo
R
Sportology Center, Juntendo University Graduate School of Medicine.
D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007294:Inositol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011236:Prediabetic State / Q000188:drug therapy*
D007004:Hypoglycemic Agents; D007294:Inositol; C102817:voglibose