Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
NCT ID: NCT00817778
Last Updated: 2012-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2009-01-31
2009-07-31
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
SINGLE
Study Groups
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AZD1656
Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
AZD1656
Subjects will be treated with tolerable dose twice daily for another 24 days.
Placebo
Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
Placebo
Subjects will be treated with tolerable dose twice daily for another 24 days.
Interventions
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AZD1656
Subjects will be treated with tolerable dose twice daily for another 24 days.
Placebo
Subjects will be treated with tolerable dose twice daily for another 24 days.
Eligibility Criteria
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Inclusion Criteria
* Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation
* HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial \[DCCT\] standard)
Exclusion Criteria
* Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus
30 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Klas Malmberg, MD, PhD, Prof
Role: STUDY_DIRECTOR
AstraZeneca R&D Mölndal
Emanuel P DeNoia, M.D
Role: PRINCIPAL_INVESTIGATOR
Healthcare Discoveries LLC Icon Development Solutions
Locations
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Research Site
San Antonio, Texas, United States
Countries
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Other Identifiers
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D1020C00019
Identifier Type: -
Identifier Source: org_study_id