Status:
COMPLETED
Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-69 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.
Detailed Description
The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Dia...
Eligibility Criteria
Inclusion
- Patients aged ≥ 20 years at the time of informed consent
- Japanese patients with type 2 diabetes
- Patients who have HbA1c ≥ 7.0% and \< 10.0% if untreated with antidiabetic agent.
- Patients who have HbA1c ≥ 6.5% and \< 9.5% if treated with antidiabetic agent.
Exclusion
- Patients aged ≥ 70 years at the time of informed consent
- Patients with a history of type 1 diabetes or diabetic ketoacidosis
- 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 an estimated glomerular filtration rate (eGFR), \< 45 mL/min per 1.73 m2
- Patients with fasting plasma glucose ≥ 240 mg/dL
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02222350
Start Date
July 1 2014
End Date
January 1 2015
Last Update
February 12 2019
Active Locations (1)
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1
Heishinkai Medical Group Incorporated OCROM Clinic
Kasuga, Osaka, Japan, 565-0853