To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients
NCT ID: NCT00916604
Last Updated: 2009-11-03
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
24 participants
INTERVENTIONAL
2009-05-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group)
AZD1656
Three increasing dose-steps with oral suspension, 8 days treatment
B
Placebo oral suspension given to 3 groups (2 on placebo in each group)
Placebo
Placebo oral suspension, 8 days treatment
Interventions
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AZD1656
Three increasing dose-steps with oral suspension, 8 days treatment
Placebo
Placebo oral suspension, 8 days treatment
Eligibility Criteria
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Inclusion Criteria
* A body mass index (BMI) of 19 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
* Systolic pressure (SBP) \> 160 mmHg or diastolic pressure (DBP) \> 95 mmHg
* 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.
30 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca Pharmaceuticals
Principal Investigators
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Klas Malmberg, MD
Role: STUDY_DIRECTOR
AstraZeneca R&D Mölndal
Takashi Eto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
PS Clinic, Fukuoka, Japan
Mitsuyasu Hokamura, MD
Role: PRINCIPAL_INVESTIGATOR
HONJO CLINIC II, Tokyo, Japan
Locations
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Research Site
Fukuoka, , Japan
Research Site
Tokyo, , Japan
Countries
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Other Identifiers
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D1020C00004
Identifier Type: -
Identifier Source: org_study_id
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