A Study of OPC-262 in Patients With Type 2 Diabetes | NCT00997282

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

NCT00997282

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Jan 8, 2014Estimated

Enrollment

255Estimated

Phase

Phase 2Phase 3

Conditions

Diabetes Type 2

Interventions

OPC-262 2.5 mg
OPC-262 5 mg
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-090904

Status Module

Record Verification Date

Jan 2014

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

Sep 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Oct 16, 2009

First Submission Date that Met QC Criteria

Oct 16, 2009

First Posted Date

Oct 19, 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

Jan 6, 2014

Last Update Posted Date

Jan 8, 2014Estimated

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

The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

255Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OPC-262 2.5 mg	Experimental	orally administered once daily for 24 weeks	Drug: OPC-262 2.5 mg
OPC-262 5 mg	Experimental	orally administered once daily for 24 weeks	Drug: OPC-262 5 mg
Placebo	Placebo Comparator	orally administered once daily for 24 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OPC-262 2.5 mg	Drug	orally administered once daily for 24 weeks	OPC-262 2.5 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in HbA1C from baseline		Week 24 (LOCF)

Secondary Outcomes

Measure	Description	Time Frame
Changes in fasting blood glucose (FBG) from baseline		Week 24
Changes in 2 hour postprandial blood glucose (PPG) from baseline		Week 24
Changes in 3 hour PPG AUC from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes patients with HbA1C above 6.5% 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 for the entire study period and for 4 weeks after the study (end of the post-observation period)

Exclusion Criteria:

Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
Patients with a medical history of diabetic coma
Patients with poorly-controlled hypertension
Patients with heart failure
Patients with a complication of active hepatitis or hepatic cirrhosis
Patients undergoing treatment of glomerular 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

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kaatsuhisa Saito	OPCJ	Study Chair

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

Facility	Status	City	State	ZIP	Country	Contacts
		Chubu Region			Japan