A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

Daiichi Sankyo

Status: Completed

Conditions: Type2 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02628392

DS8500-A-J203

Details and patient eligibility

About

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus.

Full description

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus after a 12-week oral administration of DS-8500a at 25, 50, or 75 mg in a double-blind, parallel-group comparison study. In addition, the clinical positioning of DS-8500a relative to an existing drug will be investigated using sitagliptin as a comparator.

Enrollment: 368 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 < 10.0%

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: Parallel Assignment

Masking: Quadruple Blind

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368 participants in 5 patient groups, including a placebo group

DS-8500a 25 mg QD

Experimental group

Description:

DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule

Treatment:

Drug: placebo

Drug: DS-8500a

DS-8500a 50 mg QD

Experimental group

Description:

DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule

Treatment:

Drug: placebo

Drug: DS-8500a

DS-8500a 75 mg QD

Experimental group

Description:

DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule

Treatment:

Drug: placebo

Drug: DS-8500a

placebo

Placebo Comparator group

Description:

placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively.

Treatment:

Drug: placebo

Sitagliptin

Active Comparator group

Description:

capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet

Treatment:

Drug: placebo

Drug: Sitagliptin