臨床研究等提出・公開システム

Date of registration	July. 08, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221154

Scientific Title	A 4-month Treatment, Randomized, Double-blind, Placebo-Controlled, Multi-centre, Parallel-Group Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of Different Dosing Regimens of AZD1656 as Monotherapy in Japanese Type 2 Diabetes Mellitus Patients
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	RD-clinical-information-Japan@astrazeneca.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, Double-blind, Placebo-Controlled, Multi-centre, Parallel-Group
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	- women of non-childbearing potential. - Provision of informed consent prior to any study specific procedures - Nailve T2DM patients with HbA1c 7.5% or more but 10% or less, or T2DM Patients treated with one or two oral anti-hyperglycaemic agent(s) with HbA1c 7.5% or more but 9.5% or less at enrolment visit (Visit1)
	Exclusion Criteria	- Clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, hepatic disease and haematological disease. - The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history. - Participation in another clinical trial and/or intake of another investigational drug within the last 30 days prior to enrolment visit
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Type 2 Diabetes Mellitus
Intervention(s)		investigational material(s) Generic name etc : AZD1656 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral tablet:10mg - 200mg, twice daily control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : twice daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	AstraZeneca
Secondary Sponsor

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Date of Approval by IRB

Secondary ID No.	JapicCTI-101189
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Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Jan. 12, 2017	Detail	Changes
7	Jan. 12, 2017	Detail	Changes
6	Aug. 15, 2011	Detail	Changes
5	Aug. 15, 2011	Detail	Changes
4	Mar. 15, 2011	Detail	Changes
3	Mar. 15, 2011	Detail	Changes
2	July. 08, 2010	Detail	Changes
1	July. 08, 2010	Detail

List of change history