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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00857558
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Diabetes, Type 2 Drug: saxagliptin Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
Study Start Date : January 2009
Primary Completion Date : March 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. changes in HbA1C from baseline [ Time Frame: 2w, 4w, 8w, 12w, 16w ]

Secondary Outcome Measures :
  1. values and changes in HbA1c form baseline [ Time Frame: 2w, 4w, 8w, 12w, 16w ]
  2. values and changes in fasting blood glucose (FSB) from baseline [ Time Frame: 2w, 4w, 8w, 12w, 16w ]
  3. adverse event [ Time Frame: at any time ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Co., Ltd
Investigators
Study Director: Katsuhisa Saito OPC-J
More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT00857558     History of Changes
Other Study ID Numbers: 262-08-001
JapicCTI-090697 ( Other Identifier: JAPIC )
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents