Type 2 diabetes
Conditions
Interventions
In addition to their baseline treatment, patients were randomized to receive oral voglibose (0.2 mg three times daily for 8 weeks and then 0.3 mg three times daily for 136 weeks.
In addition to their
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Absence of diabetic retinopathy, or the presence of simple background retinopathy or mild preproliferative retinopathy 2) Those who are being treated with diet or exercise with or without a sulfonylurea. 3) Fasting blood glucose level of 160 mg/dL or less at the start of the run-in period or 4 weeks after the beginning of the run-in period. 4) Mean urinary albumin-to-creatinine ratio of 300 mg/g or less creatinine at the start of the run-in period or 4 weeks after the beginning of the run-in period.
Exclusion criteria
Exclusion criteria: 1) Those who are not allowed mydriasis due to glaucoma etc. 2) History of photocoagulation 3) Those who are inable to evaluate diabetic retinopathy due to internal ophthalmic surgery, corneal diseases or cataract etc. 4) Those who experienced a cerebrovascular event during the run-in period. 5) Those who experienced a significant ECG abnormality, significant cardiac diseases (myocardial infarction or angina pectoris) or arteriosclerosis obliterans (skin ulcer, gangrene or intermittent claudication) during the run-in period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The development or progression of diabetic retinopathy and/or nephropathy. | — |
Countries
Japan
Outcome results
None listed