Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults
NCT ID: NCT01042106
Last Updated: 2013-09-16
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
40 participants
INTERVENTIONAL
2009-11-30
2010-07-31
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
QUADRUPLE
Study Groups
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DSP-8658
DSP-8658 2.5, 10, 20, 40 mg once daily
DSP-8658
Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily
Placebo
Placebo 2.5, 10, 20, and 40 mg doses once daily
Placebo
Placebo 2.5, 10, 20, 40 mg orally once daily
Interventions
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DSP-8658
Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily
Placebo
Placebo 2.5, 10, 20, 40 mg orally once daily
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index ≤45
* Drug naive type 2 diabetes or type 2 diabetes previously treated with an oral antidiabetic drug
* Age ≥ 18 and ≤ 65 years
* Body Mass Index ≥ 18 and ≤ 29
* Good health as determined by medical history, ECG, clinical chemistry, hematology, urinalysis, virology, and a physical examination.
Exclusion Criteria
* Have, or have had a history of clinically significant neurological, urological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders including cancer
18 Years
65 Years
ALL
Yes
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, MD
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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Cetero Research
San Antonio, Texas, United States
Countries
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Other Identifiers
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D6950153
Identifier Type: -
Identifier Source: org_study_id