A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes | NCT00857558

Studies
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

NCT00857558

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Mar 9, 2017Actual

Enrollment

350Actual

Phase

Phase 2

Conditions

Diabetes, Type 2

Interventions

saxagliptin
saxagliptin
saxagliptin
placebo

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
JapicCTI-090697	Other Identifier	JAPIC

Status Module

Record Verification Date

Mar 2017

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

Jan 2009

Primary Completion Date

Mar 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Mar 4, 2009

First Submission Date that Met QC Criteria

Mar 5, 2009

First Posted Date

Mar 6, 2009Estimated

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

Mar 7, 2017

Last Update Posted Date

Mar 9, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	OPC-262 1mg	Drug: saxagliptin
2	Experimental	OPC-262 2.5mg	Drug: saxagliptin
3	Experimental	OPC-262 5mg	Drug: saxagliptin
4	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
saxagliptin	Drug	orally administration at 1 mg once a day for 12 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in HbA1C from baseline		2w, 4w, 8w, 12w, 16w

Secondary Outcomes

Measure	Description	Time Frame
values and changes in HbA1c form baseline		2w, 4w, 8w, 12w, 16w
values and changes in fasting blood glucose (FSB) from baseline		2w, 4w, 8w, 12w, 16w
adverse event

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes patients with HbA1c above 7.0% and below 10%
Patients who are capable of giving informed consent
Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner

Exclusion Criteria:

Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus
Patients with a medical history of diabetes coma
Patients with poorly-controlled hypertension
Patients with heart failure
Patients with a complication of active hepatitis or hepatic cirrhosis
Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy
Patients with a history or complication of malignant tumor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Katsuhisa Saito	OPC-J	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C502994	saxagliptin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Chubu Regin			Japan