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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001393
Receipt No. R000001631
Scientific Title A Phase 2/3 Study of SYR-322 as an Add-on to a Sulfonylurea
Date of disclosure of the study information 2009/04/01
Last modified on 2009/12/08

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Basic information
Public title A Phase 2/3 Study of SYR-322 as an Add-on to a Sulfonylurea
Acronym A Phase 2/3 Study of SYR-322 as an Add-on to a Sulfonylurea
Scientific Title A Phase 2/3 Study of SYR-322 as an Add-on to a Sulfonylurea
Scientific Title:Acronym A Phase 2/3 Study of SYR-322 as an Add-on to a Sulfonylurea
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 a sulfonylurea versus sulfonylurea alone in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with a sulfonylurea 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.
Glimepiride will be administered orally 1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or 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.
Glimepiride will be administered orally 1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or 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.
Glimepiride will be administered orally 1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or 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

Not applicable
Gender Male and Female
Key inclusion criteria 1)The subject has been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period.
2)The subject has been taking sulfonylurea at a stable dose regimen for at least 12 weeks prior to the initiation of the treatment period (Week 0).
3)The subject has an HbA1c of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Key exclusion criteria The subject has taken other diabetic medications than sulfonylurea within 12 weeks before the initiation of the treatment period (Week 0).
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
Email

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/
Email

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001631

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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