UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000001393
Receipt number	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 13:44:06

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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

Type 2 diabetes mellitus

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

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

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 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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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=R000001631

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name