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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: placebo; Drug: DS-8500a 25 mg; Drug: DS-8500a 75 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02685345

DS8500-A-J204

Details and patient eligibility

About

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.

Full description

In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.

Enrollment: 85 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 3 patient groups, including a placebo group

DS-8500a 25 mg QD

Experimental group

Description:

DS-8500a 25 mg tablets, orally, once daily (QD) for up to 28 days

Treatment:

Drug: DS-8500a 25 mg

DS-8500a 75 mg QD

Experimental group

Description:

DS-8500a 75 mg tablets, orally, once daily (QD) for up to 28 days

Treatment:

Drug: DS-8500a 75 mg

placebo

Placebo Comparator group

Description:

placebo tablets, orally, once daily for up to 28 days

Treatment:

Drug: placebo