臨床研究等提出・公開システム

Date of registration	June. 10, 2008
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220567

Scientific Title	A Phase 2/3, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Alfa-glucosidase Inhibitor in Subjects With Type 2 Diabetes in Japan
Public Title	Efficacy and Safety of Alogliptin Used in Combination With Alfa-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan

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	Takeda Phamaceutical Company Limited
	Address	https://www.takeda.co.jp/contact/form/en/form/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		210
Study Type		Interventional
Study Design	Study Design	Multicenter, randomized, double-blind, parallel-group study
Study Design	Objective
Phase		2-3
Key inclusion & exclusion criteria	Inclusion Criteria	Had been receiving as table dose and regimen of an Alfa-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (Week -8) and during the screening phase. Had a glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (Week -4). Had HbA1c differences within 10.0% at the start of the screening phase (Week - 8 ) and 4 weeks after the start of the screening phase (Week -4) from the HbA1c value at the start of the screening phase. Was receiving as pecific diet therapy and an exercise therapy ( if any) for the last 4 weeks or longer before the start of the screening phase (Week -8).
	Exclusion Criteria	Had received any antidiabetic drug other than Alfa-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (Week -8) or during the screening phase.
	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 : SYR-322 INN of investigational material : Alogliptin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Alogliptin 12.5 mg, tablets , orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. Generic name etc : Basen INN of investigational material : Voglibose Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Alogliptin 12.5 mg, tablets , orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Change from Baseline in Glycosylated Hemoglobin (Week 12) Baseline and Week 12
Secondary Outcome		Change from Baseline in Glycosylated Hemoglobin, Fasting Plasma Glucose, Fasting C-peptide, Blood Glucose Insulin, Insulin, C-peptide and Glucagons Baseline and Weeks 2, 4, 6, 8 and 12

Primary Sponsor	Takeda Pharmaceutical Company Limited
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-080589
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
12	Dec. 17, 2018	(this page)	Changes
11	Feb. 17, 2014	Detail	Changes
10	Feb. 17, 2014	Detail	Changes
9	June. 03, 2011	Detail	Changes
8	June. 03, 2011	Detail	Changes
7	Feb. 03, 2011	Detail	Changes
6	Mar. 27, 2009	Detail	Changes
5	Mar. 27, 2009	Detail	Changes
4	Mar. 10, 2009	Detail	Changes
3	Mar. 10, 2009	Detail	Changes
2	June. 10, 2008	Detail	Changes
1	June. 10, 2008	Detail

List of change history