臨床研究等提出・公開システム

Date of registration	Jan. 12, 2016
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223072

Scientific Title	A phase 2, randomized, placebo-controlled, double-blind, crossover study of DS-8500a to evaluate the effects on pancreatic beta cell function in Japanese patients with type 2 diabetes mellitus
Public Title

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	DAIICHI SANKYO 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		20
Study Type		Interventional
Study Design	Study Design	Randomized, double-blind, crossover study
Study Design	Objective
Phase		2
Key inclusion & exclusion 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 < 9.0% HbA1c
	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 < 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
	Minimum Age	20age old over
	Maximum Age	No limit
	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		- First-phase secretion (Insulin and C-peptide) - Second-phase secretion (Insulin and C-peptide)
Secondary Outcome		- M value - M/I value - Disposition Index

Primary Sponsor	DAIICHI SANKYO 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-163126
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Nov. 07, 2016	Detail	Changes
7	Nov. 07, 2016	Detail	Changes
6	May. 10, 2016	Detail	Changes
5	May. 10, 2016	Detail	Changes
4	Mar. 15, 2016	Detail	Changes
3	Mar. 15, 2016	Detail	Changes
2	Jan. 12, 2016	Detail	Changes
1	Jan. 12, 2016	Detail

List of change history