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

This study has been completed.
Sponsor:
Information provided by:
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00857558
First received: March 4, 2009
Last updated: January 6, 2014
Last verified: January 2014
  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 2

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

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

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
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
OPC-262 1mg
Drug: saxagliptin
orally administration at 1 mg once a day for 12 weeks
Experimental: 2
OPC-262 2.5mg
Drug: saxagliptin
orally administration at 2.5 mg once a day for 12 weeks
Experimental: 3
OPC-262 5mg
Drug: saxagliptin
orally administration at 5 mg once a day for 12 weeks
Placebo Comparator: 4 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Chubu regin, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kinki region, Japan
Kyushu region, Japan
Shikoku region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Katsuhisa Saito OPC-J
  More Information

No publications provided

Responsible Party: Katsuhisa Saito, Senior Operating Officer, Director, Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00857558     History of Changes
Other Study ID Numbers: 262-08-001, JapicCTI-090697
Study First Received: March 4, 2009
Last Updated: January 6, 2014
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
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014