Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients
NCT ID: NCT01152385
Last Updated: 2012-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
224 participants
INTERVENTIONAL
2010-05-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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high
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
AZD1656
Oral tablet administered twice daily during 4 months
Middle
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
AZD1656
Oral tablet administered twice daily during 4 months
low
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
AZD1656
Oral tablet administered twice daily during 4 months
4
Placebo
administered twice daily during 4 months
Interventions
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AZD1656
Oral tablet administered twice daily during 4 months
Placebo
administered twice daily during 4 months
Eligibility Criteria
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Inclusion Criteria
* Provision of informed consent prior to any study specific procedures
* Naïve T2DM patients with HbA1c ≥ 7.5% but ≤ 10% or T2DM Patients treated with one or two oral anti-hyperglycaemic agent(s) with HbA1c ≥ 7.5% but ≤ 9.5% at enrolment visit (Visit1)
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Maria Leonsson-Zachrisson
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Osaka, , Japan
Research Site
Suita, , Japan
Research Site
Tokyo, , Japan
Countries
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References
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Kiyosue A, Hayashi N, Komori H, Leonsson-Zachrisson M, Johnsson E. Dose-ranging study with the glucokinase activator AZD1656 as monotherapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2013 Oct;15(10):923-30. doi: 10.1111/dom.12100. Epub 2013 Apr 22.
Other Identifiers
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D1020C00016
Identifier Type: -
Identifier Source: org_study_id