Long term effect of Japanese Kampo formula gosyajinkigan in diabetic complication; randomized open-labeled trial

INTERVENTION: Regular treatment plus Kampo formulation goshajinkigan (TJ107) every 3 preprandial for 5 years Regular treatment CONDITION: Diabetes mellitus PRIMARY OUTCOME: The prespecified primary endpoints were the first occurrence of nonfatal myocardial infarction or nonfatal stroke or one or more upstaging of diabetic nephropathy(DN) or retinopathy(DR). SECONDARY OUTCOME: body weight, blood ; pressure, fasting blood glucose, glycated hemoglobin, serum insulin (c‐peptide reactivity on insulin user) , total cholesterol, triglycelide, high density lipoprotein, serum creatinin, urea ; nitrogen and diabetic neuropathy INCLUSION CRITERIA: volunteers who had type 2 diabetes mellitus and a glycated hemoglobin level of 6.5% or more and who either were between the ages of 40 and 75 years without neither macroalbuminuria nor serum creatinin level of more than 1.3 mg per deciliter nor diabetic retinopathy over pre‐proliferative retinopathy.