UMIN ID: UMIN000001111
Registered date:07/04/2008
Long-term effects of voglibose on diabetic complication in Japanese patients with type 2 diabetes mellitus: a double-blind, randomized, placebo-controlled clinical trial
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 diabetes |
| Date of first enrollment | 2000/03/01 |
| Target sample size | 550 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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 baseline treatment, patients were randomized to receive oral matching placebo three times daily for 144 weeks. |
Outcome(s)
| Primary Outcome | The development or progression of diabetic retinopathy and/or nephropathy. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 40years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Takeda Pharmaceutical Company Limited |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Takeda Pharmaceutical Company Limited |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | Takeda Pharmaceutical Company Limited Contact for Clinical Trial Infomation |
| scientific contact | |
| Name | Yukio Shigeta |
| Address | Setatsukiwacho, Ootsu-Shi,Shiga,Japan Japan |
| Telephone | |
| Affiliation | Shiga University of Medical Science Hospital Emeritus Professor |