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Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01152385
First received: June 10, 2010
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
Results First Received: July 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: AZD1656
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment: 224 Study Start Date: May 2010 Study Completion Date: May 2011 Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Wash-out period for patients treated with anti-diabetes treatment at enrolment.

Reporting Groups
  Description
High Dose 200 mg (daily dose)
Middle Dose 140 mg (daily dose)
Low Dose 80 mg (daily dose)
Placebo Placebo

Participant Flow:   Overall Study
    High Dose     Middle Dose     Low Dose     Placebo  
STARTED     55     58     56     55  
COMPLETED     46     52     51     50  
NOT COMPLETED     9     6     5     5  
Withdrawal by Subject                 3                 1                 1                 1  
Protocol Violation                 0                 0                 0                 1  
Adverse Event                 1                 1                 0                 0  
Study-specific withdrawal criteria                 1                 1                 2                 0  
Unspecified                 4                 3                 2                 3  



  Baseline Characteristics
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Reporting Groups
  Description
High Dose 200 mg (daily dose)
Middle Dose 140 mg (daily dose)
Low Dose 80 mg (daily dose)
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    High Dose     Middle Dose     Low Dose     Placebo     Total  
Number of Participants  
[units: participants]
 		  55     58     56     55     224  
Age  
[units: Years]
Mean ± Standard Deviation 		  57  ± 9     55  ± 9     55  ± 10     57  ± 9     56  ± 9  
Gender  
[units: Participants]
 		         
Female     7     8     8     9     32  
Male     48     50     48     46     192  



  Outcome Measures
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1.  Primary:   Change in Haemoglobin A1c (HbA1c)   [ Time Frame: from baseline to 4 months ]
  Show Outcome Measure 1

2.  Secondary:   Change in Fasting Plasma Glucose (FPG)   [ Time Frame: from baseline to 4 months ]
  Show Outcome Measure 2

3.  Secondary:   Number of Responders in Terms of HbA1C ≤ 7%   [ Time Frame: at 4th month ]
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4.  Secondary:   Number of Responders in Terms of HbA1C ≤ 6.5%   [ Time Frame: at 4th month ]
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5.  Secondary:   Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)   [ Time Frame: from baseline to 4 months ]
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6.  Secondary:   Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)   [ Time Frame: from baseline to 4 months ]
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7.  Secondary:   Percentage Change in Triglycerides   [ Time Frame: from baseline to 4 months ]
  Show Outcome Measure 7

8.  Secondary:   Change in High-sensitivity C-reactive Protein (Hs-CRP)   [ Time Frame: from baseline to 4 months ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
phone: +44 1625 518062
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01152385     History of Changes
Other Study ID Numbers: D1020C00016
Study First Received: June 10, 2010
Results First Received: July 24, 2012
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency