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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:
NCT01046318
First received: January 6, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose
The purpose of this clinical study is to evaluate the safety and efficacy of OPC-262 5 mg in patients with type 2 diabetes by repeated administration orally for 52 weeks.

Condition Intervention Phase
Type 2 Diabetes Drug: OPC-262 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term Study of OPC-262 in Patients With Type 2 Diabetes

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF) [ Time Frame: each visit (OC) and Week 52 (LOCF) ]
  • Clinical laboratory tests [ Time Frame: every 4 weeks ]

Secondary Outcome Measures:
  • Changes in fasting blood glucose (FBG) from baseline to each visit (OC) and Week 52 (LOCF) [ Time Frame: each visit (OC) and Week 52 (LOCF) ]

Enrollment: 100
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC-262 5 mg
OPC-262 5 mg will be orally administered once daily fro 52 weeks.
Drug: OPC-262
OPC-262 5 mg will be orally administered once daily fro 52 weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes patients with HbA1C above 6.5% and below 10% at both of the time of the 1st and the 2nd screening examinations and who have been undergoing diet and exercise therapies only for at least 8 weeks prior to the 1st screening examination
  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
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: NCT01046318

Locations
Japan
Chubu Region, Japan
Kanto Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01046318     History of Changes
Other Study ID Numbers: 262-09-004
JapicCTI-090952 ( Registry Identifier: JAPIC )
Study First Received: January 6, 2010
Last Updated: January 6, 2014

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

ClinicalTrials.gov processed this record on June 22, 2017