UMIN ID: UMIN000001110
Registered date:04/04/2008
Clinical study of combinational therapy of AD-4833 with metformin -Phase III double-blind comparative study-
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Type2 Diabetes |
| Date of first enrollment | 2005/04/01 |
| Target sample size | 160 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | [Metformin] Metformin is orally administered at fixed doses throughout the baseline observation period and the treatment period. [AD-4833] In Period I, one AD-4833 15 mg tablet is orally administered once daily before or after breakfast for 12 weeks. When there is no tolerability problem after 12 weeks of the treatment period, the study proceed to Period II, and one AD-4833 30 mg tablet is administered once daily before or after breakfast for 16 weeks. When there is any tolerability problem, the same study medication as in Period I is continued through the end of Period II or the medication is discontinued, depending on the degree of the problem. [Metformin] Metformin is orally administered at fixed doses throughout the baseline observation period and the treatment period. [AD-4833] In Period I, one AD-4833 placebo tablet is orally administered once daily before or after breakfast for 12 weeks. When there is no tolerability problem after 12 weeks of the treatment period, the study proceed to Period II, and one AD-4833 placebo tablet is administered once daily before or after breakfast for 16 weeks. When there is any tolerability problem, the same study medication as in Period I is continued through the end of Period II or the medication is discontinued, depending on the degree of the problem. |
Outcome(s)
| Primary Outcome | Change in HbA1C at the end of the treatment period |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)Type 1 diabetes (2)Those who have used different medication for diabetes from metformin-alone (including insulin) period,or have changed the diet therapy and exercise therapy during 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 | Kohei Kaku |
| Address | 577 Matsushima Kurashiki-shi, Okayama,Japan. Japan |
| Telephone | |
| Affiliation | Kawasaki Medical School Diabetes and Endocrine Division, Department of Medicine |