Study of Combination Therapy With SYR-322 | NCT01521962

Studies
Study of Combination Therapy With SYR-322

NCT01521962

Sponsor

Takeda

Status

Completed

Last Update Posted

Nov 13, 2013Estimated

Enrollment

67Actual

Phase

Phase 3

Conditions

Diabetes Mellitus

Interventions

Alogliptin
Insulin

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1127-1525	Registry Identifier	WHO
JapicCTI-121736	Registry Identifier	JapicCTI

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jan 26, 2012

First Submission Date that Met QC Criteria

Jan 30, 2012

First Posted Date

Jan 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2013

Last Update Posted Date

Nov 13, 2013Estimated

Description Module

Brief Summary

To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SYR-322 (Alogliptin) QD	Experimental	SYR-322 25 mg, orally.	Drug: Alogliptin
Insulin	Placebo Comparator	injection	Drug: Insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alogliptin	Drug	Alogliptin tablets	SYR-322 (Alogliptin) QD	SYR-322

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value)		Baseline and Week 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject is an outpatient.
The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

The subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Senior Manager	Takeda	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25190226	Derived	Kaku K, Mori M, Kanoo T, Katou M, Seino Y. Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase. Expert Opin Pharmacother. 2014 Oct;15(15):2121-30. doi: 10.1517/14656566.2014.956722. Epub 2014 Sep 5.

Facility	Status	City	State	ZIP	Country	Contacts
		Aomori	Aomori		Japan

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones