Trial | NCT02685345  Report issue

Title

A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin
A Phase 2, Randomized, Double-blind, Placebo-controlled, add-on Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus Receiving Sitagliptin

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ds-8500a ...

  • Study Participants

    85
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.
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.
Study Started
Jan 31
2016
Primary Completion
Sep 30
2016
Study Completion
Oct 31
2016
Last Update
Feb 12
2019

Drug DS-8500a 25 mg

Drug DS-8500a 75 mg

Drug placebo

DS-8500a 25 mg QD Experimental

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

DS-8500a 75 mg QD Experimental

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

placebo Placebo Comparator

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

Criteria 

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
No Results Posted