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Clinical trial

12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

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Last updated:1st Jan 2016

The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled With Active Comparator, 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin
Estimated Enrollment: 260
Study Start Date: January 2016
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
DS-8500a 25mg
- Experimental: DS-8500a 50 mg
- Experimental: DS-8500a 75 mg
- Placebo Comparator: placebo
- Active Comparator: Sitagliptin 100 mg

Category Value
Study start date 2016-01-01

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