NIPH Clinical Trials Search

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) studiedType 2 diabetes
Date of first enrollment2000/03/01
Target sample size550
Countries of recruitmentJapan
Study typeInterventional
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.


Primary OutcomeThe development or progression of diabetic retinopathy and/or nephropathy.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum40years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Address Japan
Affiliation Takeda Pharmaceutical Company Limited Contact for Clinical Trial Infomation
scientific contact
Name Yukio Shigeta
Address Setatsukiwacho, Ootsu-Shi,Shiga,Japan Japan
Affiliation Shiga University of Medical Science Hospital Emeritus Professor