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

This study is currently recruiting participants.

Verified by Otsuka Pharmaceutical Co., Ltd., March 2009

First Received: March 4, 2009 Last Updated: March 5, 2009 History of Changes

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00857558

Purpose

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

Condition	Intervention	Phase
Diabetes, Type 2	Drug: saxagliptin Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Saxagliptin

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

changes in HbA1C from baseline [ Time Frame: 2w, 4w, 8w, 12w, 16w ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

values and changes in HbA1c form baseline [ Time Frame: 2w, 4w, 8w, 12w, 16w ] [ Designated as safety issue: No ]
values and changes in fasting blood glucose (FSB) from baseline [ Time Frame: 2w, 4w, 8w, 12w, 16w ] [ Designated as safety issue: No ]
adverse event [ Time Frame: at any time ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	280
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental OPC-262 1mg	Drug: saxagliptin orally administration at 1 mg once a day for 12 weeks
2: Experimental OPC-262 2.5mg	Drug: saxagliptin orally administration at 2.5 mg once a day for 12 weeks
3: Experimental OPC-262 5mg	Drug: saxagliptin orally administration at 5 mg once a day for 12 weeks
4: Placebo Comparator	Drug: placebo orally administration once a day for 12 weeks

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857558

Contacts

Contact: Drug Information Center

opc_ctr@otsuka.jp

Locations

Japan
	Recruiting
Kanto region, Japan
	Recruiting
Hokkaido region, Japan
	Recruiting
Tohoku region, Japan
	Recruiting
Chubu regin, Japan
	Recruiting
Kyushu region, Japan
	Recruiting
Chugoku region, Japan
	Recruiting
Shikoku region, Japan
	Recruiting
Kinki region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director:

Katsuhisa Saito

OPC-J

More Information

No publications provided

Responsible Party:	Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd. ( Katsuhisa Saito, Senior Operating Officer, Director )
Study ID Numbers:	262-08-001, JapicCTI-090697
Study First Received:	March 4, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00857558 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009