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

Daiichi Sankyo

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: placebo; Drug: DS-8500a

Study type: Interventional

Funder types: Industry

Identifiers

NCT02669732

DS8500-A-J205

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

DS-8500a 75 mg once daily (QD)

Experimental group

Description:

tablets, orally, once daily for up to 28 days

Treatment:

Drug: DS-8500a

Placebo

Placebo Comparator group

Description:

tablets, orally, once daily for up to 28 days

Treatment:

Drug: placebo