UMIN ID: UMIN000001109
Registered date:07/04/2008
A study in subjects with impaired glucose tolerance (IGT) to evaluate effects of AO-128 on prevention of type 2 diabetes mellitus (Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Impaired glucose tolerance (IGT) |
| Date of first enrollment | 2003/04/01 |
| Target sample size | 1782 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | AO-128 (Voglibose) 0.2mg tab. tid At least 144 weeks, or by progression type 2 diabetes or improvement to normal OGTT Placebo tab. tid At least 144 weeks, or by progression type 2 diabetes or improvement to normal OGTT |
Outcome(s)
| Primary Outcome | Progression from IGT to type 2 diabetes mellitus |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 30years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Patient has a history of diabetes mellitus 2. Patient with serious hepatic or renal disorders |
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 Information |
| scientific contact | |
| Name | Ryuzo Kawamori |
| Address | 2-1-1, Hongo, Bunkyo-ku,Tokyo, Japan Japan |
| Telephone | |
| Affiliation | Juntendo University, school of medicine Department of Medicine, Metabolism and Endocrinology |