UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001381 |
|---|---|
| Receipt number | R000001364 |
| Scientific Title | A Phase 2/3 Study of SYR-322 as an Add-on to an Alpha-Glucosidase Inhibitor |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2008/09/18 09:34:29 |
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Basic information
Public title
A Phase 2/3 Study of SYR-322 as an Add-on to an Alpha-Glucosidase Inhibitor
Acronym
A Phase 2/3 Study of SYR-322 as an Add-on to an Alpha-Glucosidase Inhibitor
Scientific Title
A Phase 2/3 Study of SYR-322 as an Add-on to an Alpha-Glucosidase Inhibitor
Scientific Title:Acronym
A Phase 2/3 Study of SYR-322 as an Add-on to an Alpha-Glucosidase Inhibitor
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of SYR-322 at a dose of 12.5 or 25 mg as an add-on to an Alpha-glucosidase inhibitor in comparison with the Alpha-glucosidase inhibitor alone in type 2 diabetic patients who had inadequate glycemic control with an Alpha-glucosidase inhibitor as well as diet and exercise therapies in a randomized, double-blind, parallel-group design.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c change at the completion of treatment from baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Each subject will orally receive SYR-322 12.5mg once daily before breakfast for 12 weeks.
Voglibose 0.2mg will also be administered orally three times daily before each meal for 20 weeks(8 weeks screening plus 12 weeks treatment).
Interventions/Control_2
Each subject will orally receive SYR-322 25mg once daily before breakfast for 12 weeks.
Voglibose 0.2mg will also be administered orally three times daily before each meal for 20 weeks(8 weeks screening plus 12 weeks treatment).
Interventions/Control_3
Each subject will orally receive Placebo once daily before breakfast for 12 weeks.
Voglibose 0.2mg will also be administered orally three times daily before each meal for 20 weeks(8 weeks screening plus 12 weeks treatment).
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The subject has been taking a stable dosage regimen of an Alpha-glucosidase inhibitor for the last 4 weeks or longer prior to the initiation of screening period(week -8) and during the screening period.
2)The subject has an HbA1c value of 6.5% or more and below 10.0% at 4 weeks after the initiation of screening period (week -4).
3)The subject is receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (week -8).
Key exclusion criteria
The subject has taken any antidiabetic medications except Alpha-glucosidase inhibitors within the last 4 weeks prior to the initiation of screening period(week -8) and during screening period.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohei Kaku |
Organization
Department of Medicine, Kawasaki Medical School
Division name
Diabetes and Endocrine Division
Zip code
Address
577,Matsushima,kurashiki-Shi,Okayama,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Takeda Pharmaceutical Company Limited
Division name
Contact for Clinical Trial Infomation
Zip code
Address
TEL
Homepage URL
https://www.takeda.co.jp/contact/form/jp/form/
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 18 | Day |
Last modified on
| 2008 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001364
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