臨床研究等提出・公開システム

Date of registration	June. 30, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222546

Scientific Title	Phase 2 study to evaluate efficacy and safety of DS-8500a in patients with Type 2 Diabetes Mellitus
Public Title	Phase 2 study of DS-8500a

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHISANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		90
Study Type		Interventional
Study Design	Study Design	Randomized, double-blind, parallel-group study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Main Inclusion Criteria; Type 2 Diabetes Mellitus
	Exclusion Criteria	Main Exclusion Criteria; Type 1 Diabetes Mellitus Patients under insulin treatment Patients with hepatic disorder Patients with renal disorder
	Minimum Age	20age old over
	Maximum Age	69age old under
	Gender	Both
Health Condition or Problem Studied		Type 2 Diabetes Mellitus
Intervention(s)		investigational material(s) Generic name etc : DS-8500a INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		24hr-weighted mean glucose
Secondary Outcome		Safety, Pharmacokinetics

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-142597
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	April. 21, 2015	Detail	Changes
3	April. 21, 2015	Detail	Changes
2	June. 30, 2014	Detail	Changes
1	June. 30, 2014	Detail

List of change history