use prior to study enrollment; participation in another clinical trial within 30 days of screening;
long-term diabetic complications such as diabetic retinopathy, diabetic neuropathy which need therapy (painful peripheral neuropathy, systemic orthostatic hypotension, urinary retention, foot ulcers or gastric stasis); a body mass index (BMI) less than 18 or greater than 38; or a body weight variation more than 10% during the screening period.