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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00997282
First received: October 16, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Type 2
 Drug: OPC-262 2.5 mg
Drug: OPC-262 5 mg
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arms Parallel Group Comparative Study of OPC-262 in Patients With Type 2 Diabetes (Phase 2/3 Study)

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Changes in HbA1C from baseline [ Time Frame: Week 24 (LOCF) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in fasting blood glucose (FBG) from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Changes in 2 hour postprandial blood glucose (PPG) from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Changes in 3 hour PPG AUC from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 255
Study Start Date: September 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC-262 2.5 mg
orally administered once daily for 24 weeks
 Drug: OPC-262 2.5 mg
orally administered once daily for 24 weeks
Experimental: OPC-262 5 mg
orally administered once daily for 24 weeks
 Drug: OPC-262 5 mg
orally administered once daily for 24 weeks
Placebo Comparator: Placebo
orally administered once daily for 24 weeks
 Drug: Placebo
orally administered once daily for 24 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes patients with HbA1C above 6.5% and below 10%
  2. Patients who are capable of giving informed consent
  3. 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:

  1. Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
  2. Patients with a medical history of diabetic coma
  3. Patients with poorly-controlled hypertension
  4. Patients with heart failure
  5. Patients with a complication of active hepatitis or hepatic cirrhosis
  6. Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
  7. Patients with a history or complication of malignant tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997282

Locations
Japan
Chubu Region, Japan
Chugoku Region, Japan
Kansai Region, Japan
Kanto Region, Japan
Kyushu Region, Japan
Shikoku Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Chair: Kaatsuhisa Saito OPCJ
  More Information

No publications provided

Responsible Party: Katsuhisa Saito, Senior Operating Officer, Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00997282     History of Changes
Other Study ID Numbers: 262-09-001, JapicCTI-090904
Study First Received: October 16, 2009
Last Updated: June 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013