Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Firuglipel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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