Unique ID issued by UMIN | UMIN000001382 |
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Receipt number | R000001366 |
Scientific Title | A Phase 2/3 Study of SYR-322 as an Add-on to a Thiazolidine |
Date of disclosure of the study information | 2008/10/01 |
Last modified on | 2009/03/19 08:59:13 |
A Phase 2/3 Study of SYR-322 as an Add-on to a Thiazolidine
A Phase 2/3 Study of SYR-322 as an Add-on to a Thiazolidine
A Phase 2/3 Study of SYR-322 as an Add-on to a Thiazolidine
A Phase 2/3 Study of SYR-322 as an Add-on to a Thiazolidine
Japan |
Type 2 diabetes mellitus
Medicine in general |
Others
NO
To evaluate the efficacy and safety of SYR-322 at a dose of 12.5 or 25 mg as an add-on to pioglitazone in comparison with pioglitazone alone in type 2 diabetic patients who had inadequate glycemic control with pioglitazone as well as diet and exercise therapies in a stratified randomization, double-blind, parallel-group design.
Safety,Efficacy
HbA1c change at the completion of treatment from baseline
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
3
Prevention
Medicine |
Each subject will orally receive SYR-322 12.5mg once daily before breakfast for 12 weeks.
Pioglitazone will be administered as 15 mg or 30 mg once daily before breakfast for 28 weeks(16 weeks screening plus 12 weeks treatment).
Each subject will orally receive SYR-322 25mg once daily before breakfast for 12 weeks.
Pioglitazone will be administered as 15 mg or 30 mg once daily before breakfast for 28 weeks(16 weeks screening plus 12 weeks treatment).
Each subject will orally receive placebo once daily before breakfast for 12 weeks.
Pioglitazone will be administered as 15 mg or 30 mg once daily before breakfast for 28 weeks(16 weeks screening plus 12 weeks treatment).
20 | years-old | <= |
Not applicable |
Male and Female
1)The subject has been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the initiation of the treatment period (Week 0)
2)The subject has an HbA1c of 6.5% or more and below 10.0% at 14 weeks after the initiation of the observation period (Week -2)
3)The subject is receiving specific diet and exercise therapies (if any) during the observation period
1)The subject has taken other diabetic medications than pioglitazone within 16 weeks before the initiation of the treatment period (Week 0)
2)The subject with a history or symptoms of cardiac failure
240
1st name | |
Middle name | |
Last name | Kohei Kaku |
Department of Medicine, Kawasaki Medical School
Diabetes and Endocrine Division
577,Matsushima,kurashiki-Shi,Okayama,Japan
1st name | |
Middle name | |
Last name |
Takeda Pharmaceutical Company Limited
Contact for Clinical Trial Infomation
https://www.takeda.co.jp/contact/form/jp/form/
Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited
Profit organization
NO
2008 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2007 | Year | 11 | Month | 01 | Day |
2007 | Year | 11 | Month | 01 | Day |
2008 | Year | 11 | Month | 01 | Day |
2008 | Year | 11 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2008 | Year | 12 | Month | 01 | Day |
2008 | Year | 09 | Month | 18 | Day |
2009 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001366
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