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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: 10mg DS-8500a tablet; Drug: placebo; Drug: 75mg DS-8500a tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02222350

DS8500-A-J201

Details and patient eligibility

About

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.

Full 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 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design. The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.

Enrollment: 100 patients

Sex: All

Ages: 20 to 69 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 < 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups, including a placebo group

DS-8500a 10mg once daily

Experimental group

Description:

10mg DS-8500a tablet given orally once daily

Treatment:

Drug: 10mg DS-8500a tablet

DS8500a 75 mg once daily

Experimental group

Description:

75mg DS-8500a tablet given orally once daily

Treatment:

Drug: 75mg DS-8500a tablet

placebo to match DS-8500a tablet

Placebo Comparator group

Description:

placebo matching DS-8500a tablet

Treatment:

Drug: placebo