An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp

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

Summary

The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.

• Phase: N/A
• 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 < 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