A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.

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

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Collaborator: Mediscience Planning, Inc.
• Treatments: Firuglipel; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Japanese patients with type 2 diabetes

• 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 with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or 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 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