臨床研究等提出・公開システム

Date of registration	July. 07, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220768

Scientific Title	A Randomized, Single-Blind, Placebo-Controlled, Multi-Centre, PhaseI Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM 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	Treatment, Randomized, Single-Blind(Subject), Parallel Assignment, Safety Study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- A body mass index (BMI) of 18 to 27 kg/m2. - Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.
	Exclusion Criteria	- Renal dysfunction GFR <60mL/min. - Systolic pressure (SBP) >160mmHg or diastolic pressure (DBP) >95mmHg. - Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP. - History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
	Minimum Age	30age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Type 2 Diabetes
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 : Three increasing dose-steps with oral suspension control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo oral suspension
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	AstraZeneca
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-090796
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 20, 2016	Detail	Changes
7	Dec. 20, 2016	Detail	Changes
6	Nov. 18, 2009	Detail	Changes
5	Nov. 18, 2009	Detail	Changes
4	Nov. 04, 2009	Detail	Changes
3	Nov. 04, 2009	Detail	Changes
2	July. 07, 2009	Detail	Changes
1	July. 07, 2009	Detail

List of change history