臨床研究等提出・公開システム

Date of registration	Oct. 03, 2005
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220136

Scientific Title	Clinical investigation for combination therapy of KAD-1229 and Pioglitazone.
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	Kissei Pharmaceutical Co., Ltd.
	Address	rinsyousiken@pharm.kissei.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Double-blind, Parallel group comparison
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Main Inclusion Criteria: - Type 2 diabetic outpatients, aged 20 years or older, who are treated with diet and stable dose of pioglitazone monotherapy. - HbA1c and post prandial glucose are within a certain range Main Exclusion Criteria: - Patients who require treatment with insulin. - Patients complicated with severe diabetic microangiopathy (neuropathy, retinopathy or nephropathy). - Patients complicated with severe cardiac disease, hepatic disease, renal disease or hypertension.
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Type 2 diabetes
Intervention(s)		investigational material(s) Generic name etc : KAD-1229 (mitiglinide) 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		Efficacy, Safety
Secondary Outcome

Primary Sponsor	KISSEI PHARMACEUTICAL 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-050138
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	June. 16, 2010	Detail	Changes
7	June. 16, 2010	Detail	Changes
6	April. 02, 2010	Detail	Changes
5	April. 02, 2010	Detail	Changes
4	Nov. 28, 2007	Detail	Changes
3	Nov. 28, 2007	Detail	Changes
2	Oct. 03, 2005	Detail	Changes
1	Oct. 03, 2005	Detail

List of change history