A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
NCT ID: NCT02628392
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
NA
368 participants
INTERVENTIONAL
2015-11-30
2016-09-30
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 tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule
DS-8500a
DS-8500a tablets 25mg, 50mg, 75mg
placebo
matching DS-8500a tablets and sitagliptin capsules
DS-8500a 50 mg QD
DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
DS-8500a
DS-8500a tablets 25mg, 50mg, 75mg
placebo
matching DS-8500a tablets and sitagliptin capsules
DS-8500a 75 mg QD
DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
DS-8500a
DS-8500a tablets 25mg, 50mg, 75mg
placebo
matching DS-8500a tablets and sitagliptin capsules
placebo
placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively.
placebo
matching DS-8500a tablets and sitagliptin capsules
Sitagliptin
capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet
Sitagliptin
capsules
placebo
matching DS-8500a tablets and sitagliptin capsules
Interventions
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DS-8500a
DS-8500a tablets 25mg, 50mg, 75mg
Sitagliptin
capsules
placebo
matching DS-8500a tablets and sitagliptin capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Japanese patients with type 2 diabetes
* Patients who have HbA1c ≥ 7.0% and \< 10.0%
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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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Heishinkai Medical Group Incorporated OCROM Clinic
Suita-shi, Osaka, Japan
Countries
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Other Identifiers
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DS8500-A-J203
Identifier Type: -
Identifier Source: org_study_id
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