Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea
NCT ID: NCT00995787
Last Updated: 2010-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
75 participants
INTERVENTIONAL
2009-10-31
2010-02-28
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
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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AZD1656
AZD1656
Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days
Placebo
Placebo
Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days
Interventions
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AZD1656
Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days
Placebo
Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days
Eligibility Criteria
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Inclusion Criteria
* Patients treated with a combination of Metformin and SU (glyburide, glimepiride, glibenclamide, glipizide or gliclazide) in stable doses for at least 2 months prior to enrolment visit
* Patients should have FPG in the range of 6,0 to 14 mmol/L (108 to 250 mg/dL) at enrolment and on the morning of randomisation
Exclusion Criteria
* Impaired renal function in terms of GFR\<60 ml/min
* Use of insulin, glitazones, gemfibrozil, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, e.g., ketoconazole within 14 days before randomisation
30 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Klas Malmberg, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
Marcus Dr. Marcus Hompesch, Dr
Role: PRINCIPAL_INVESTIGATOR
Profil Institute for Clinical Research Inc.855 3rd Avenue, Suite 4400Chula VistaCA 91911, USA
Locations
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Research Site
San Diego, California, United States
Countries
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Other Identifiers
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D1020C00026
Identifier Type: -
Identifier Source: org_study_id