A phase 2, randomized, double-blind, dose finding study of DS-8500a in Japanese patients with type 2 diabetes mellitus

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223014

Enrollment

335

Registered

2015-11-13

Start date

2015-11-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

investigational material(s) Generic name etc : DS-8500a INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main Inclusion Criteria; 1)Patients aged >= 20 years 2)Japanese patients with type 2 diabetes mellitus 3)Patients who have >= 7.0% and < 10.0% HbA1c

Exclusion criteria

Exclusion criteria: Main 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 = 35.0 kg/m2 -Patients with clinically evident renal impairment (estimated glomerular filtration rate [eGFR] of = 240 mg/dL

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c	—

Secondary

Measure	Time frame
-Change from baseline (Day -1) in HbA1c at Weeks 4 and 8 -Proportion of subjects who have achieved HbA1c of < 7.0% at Weeks 4, 8, and 12 -Change from baseline (Day -1) in fasting blood glucose at Weeks 2, 4, 8, and 12	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026