JRCT ID: jRCT2080221154
Registered date:08/07/2010
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Type 2 Diabetes Mellitus |
Date of first enrollment | 08/07/2010 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
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 |
Outcome(s)
Primary Outcome | |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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) |
Exclude 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 |
Related Information
Primary Sponsor | AstraZeneca |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-101189 |
Contact
Public contact | |
Name | |
Address | RD-clinical-information-Japan@astrazeneca.com |
Telephone | |
Affiliation | AstraZeneca KK |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |