A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin
NCT ID: NCT02685345
Last Updated: 2019-02-12
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
PHASE2
85 participants
INTERVENTIONAL
2016-01-31
2016-10-31
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
QUADRUPLE
Study Groups
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DS-8500a 25 mg QD
DS-8500a 25 mg tablets, orally, once daily (QD) for up to 28 days
DS-8500a 25 mg
DS-8500a 75 mg QD
DS-8500a 75 mg tablets, orally, once daily (QD) for up to 28 days
DS-8500a 75 mg
placebo
placebo tablets, orally, once daily for up to 28 days
placebo
Interventions
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DS-8500a 25 mg
DS-8500a 75 mg
placebo
Eligibility Criteria
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Inclusion Criteria
* Patients aged ≥ 20 years at the time of informed consent
* Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus
* Patients who have HbA1c ≥ 7.0% and \< 9.0%
Exclusion Criteria
* Patients receiving or requiring treatment with insulin
* Patients with a body mass index (BMI) of \< 18.5 kg/m2 or ≥ 35.0 kg/m2
* Patients with clinically evident renal impairment (estimated glomerular filtration rate \[eGFR\] of \< 45 mL/min per 1.73 m2) or clinically significant renal disease
* Patients with fasting plasma glucose ≥ 240 mg/dL
20 Years
ALL
No
Sponsors
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Mediscience Planning, Inc.
INDUSTRY
Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yasuo Terauchi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yokohama City University
Locations
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Yodogawaku, Osaka, Japan
Countries
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Other Identifiers
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DS8500-A-J204
Identifier Type: -
Identifier Source: org_study_id
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