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

March 4, 2009
January 6, 2014
January 2009
March 2010   (final data collection date for primary outcome measure)
changes in HbA1C from baseline [ Time Frame: 2w, 4w, 8w, 12w, 16w ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00857558 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes, Type 2
  • Drug: saxagliptin
    orally administration at 1 mg once a day for 12 weeks
  • Drug: saxagliptin
    orally administration at 2.5 mg once a day for 12 weeks
  • Drug: saxagliptin
    orally administration at 5 mg once a day for 12 weeks
  • Drug: placebo
    orally administration once a day for 12 weeks
  • Experimental: 1
    OPC-262 1mg
    Intervention: Drug: saxagliptin
  • Experimental: 2
    OPC-262 2.5mg
    Intervention: Drug: saxagliptin
  • Experimental: 3
    OPC-262 5mg
    Intervention: Drug: saxagliptin
  • Placebo Comparator: 4
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
May 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00857558
262-08-001, JapicCTI-090697
No
Katsuhisa Saito, Senior Operating Officer, Director, Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
Kyowa Hakko Kirin Company, Limited
Not Provided
Study Director: Katsuhisa Saito OPC-J
Kyowa Hakko Kirin Company, Limited
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP