UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001394 |
|---|---|
| Receipt number | R000001638 |
| Scientific Title | A Phase 2/3 Study of SYR-322 as an Add-on to a Metformin |
| Date of disclosure of the study information | 2009/04/01 |
| Last modified on | 2009/12/08 13:43:36 |
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Basic information
Public title
A Phase 2/3 Study of SYR-322 as an Add-on to a Metformin
Acronym
A Phase 2/3 Study of SYR-322 as an Add-on to a Metformin
Scientific Title
A Phase 2/3 Study of SYR-322 as an Add-on to a Metformin
Scientific Title:Acronym
A Phase 2/3 Study of SYR-322 as an Add-on to a Metformin
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 metformin versus metformin alone in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies in a randomized, double-blind, parallel-group comparative 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 12.5 mg once daily before breakfast.
Metformin will be administered orally 500 mg/day, twice daily after meal, or 750 mg thrice daily after meal for 24 weeks (12 weeks screening period plus 12 weeks treatment period).
Interventions/Control_2
Each subject will orally receive SYR-322 25 mg once daily before breakfast.
Metformin will be administered orally 500 mg/day, twice daily after meal, or 750 mg thrice daily after meal for 24 weeks (12 weeks screening period plus 12 weeks treatment period).
Interventions/Control_3
Each subject will orally receive SYR-322 placebo once daily before breakfast.
Metformin will be administered orally 500 mg/day, twice daily after meal, or 750 mg thrice daily after meal for 24 weeks (12 weeks screening period plus 12 weeks treatment period).
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)The subject has been taking metformin at a stable dose regimen for at least 12 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 8 weeks after the initiation of the observation period (Week -4).
Key exclusion criteria
1)The subject has taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
2)The subject with a history or symptoms of lactic acidosis.
Target sample size
240
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 Information
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
| 2009 | Year | 04 | 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
| 2008 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 26 | Day |
Last modified on
| 2009 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001638
