A phase 2, randomized, double-blind, placebo-controlled, add-on study of DS-8500a in Japanese patients with type 2 diabetes mellitus receiving sitagliptin

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223082

Enrollment

Registered

2016-01-20

Start date

2016-01-20

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)Japanese patients with type 2 diabetes mellitus 2)Patients aged >= 20 years 3)Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus 4)Patients who have >= 7.0% and < 9.0% 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 24hr-weighted mean glucose	—

Secondary

Measure	Time frame
-Change from baseline (Day -1) in fasting plasma glucose -Change in plasma glucose, glycoalbumin, serum insulin, proinsulin, C-peptide, PYY, total GLP-1, active GLP-1, total GIP, and glucagon at each matched time point from baseline (Day -1) -Change in pharmacodynamic parameters including plasma glucose, serum insulin, C-peptide, PYY, total GLP-1, active GLP-1, total GIP, and glucagon from baseline (Day -1) to Day 28 -Change from baseline (Day -1) in total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride	—

Measure

Time frame

-Change from baseline (Day -1) in fasting plasma glucose -Change in plasma glucose, glycoalbumin, serum insulin, proinsulin, C-peptide, PYY, total GLP-1, active GLP-1, total GIP, and glucagon at each matched time point from baseline (Day -1) -Change in pharmacodynamic parameters including plasma glucose, serum insulin, C-peptide, PYY, total GLP-1, active GLP-1, total GIP, and glucagon from baseline (Day -1) to Day 28 -Change from baseline (Day -1) in total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride

—

Outcome results

None listed

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