The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus (SUNSHINE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01608724
First received: May 28, 2012
Last updated: December 31, 2015
Last verified: December 2015
Results First Received: May 14, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Non-Insulin-Dependent
Intervention: Drug: Saxagliptin

  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
This study was conducted at 92 study centers in China. First subject enrolled: 28 Nov 2012; Last subject last visit: 16 May 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 2165 patients were screened and 741 patients were excluded due to violation of any inclusion and exclusion criteria.

Reporting Groups
  Description
Saxagliptin Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks

Participant Flow:   Overall Study
    Saxagliptin  
STARTED     1423 [1]
Treated     1361  
COMPLETED     1180  
NOT COMPLETED     243  
Withdrawal by Subject                 131  
Lost to Follow-up                 41  
Study-specific discontinuation criteria                 32  
Adverse Event                 29  
Protocol Violation                 6  
bood sugar too high, etc.                 3  
Safety reasons                 1  
[1] One patient was excluded because the Informed Consent Form was destroyed by site staff by mistake.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.

Reporting Groups
  Description
Saxagliptin Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks

Baseline Measures
    Saxagliptin  
Number of Participants  
[units: participants]
  1210  
Age  
[units: years]
Mean (Standard Deviation)
  52.3  (10.99)  
Age, Customized  
[units: Participants]
 
<65 years     1063  
>=65 years     147  
Gender  
[units: Participants]
 
Female     461  
Male     749  
Race/Ethnicity, Customized  
[units: Participants]
 
Asian     1210  
Race/Ethnicity, Customized  
[units: Participants]
 
Chinese     1210  
Baseline haemoglobin A1c (HbA1c)  
[units: %]
Mean (Standard Deviation)
  8.85  (0.929)  
Baseline fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  9.08  (2.244)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Absolute Change From Baseline in Haemoglobin A1c (HbA1c)   [ Time Frame: Weeks 6, 12, and 24 ]

2.  Secondary:   Proportion (%) of Patients Achieving HbA1c <7%   [ Time Frame: Weeks 6, 12, and 24 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG)   [ Time Frame: Weeks 6, 12, 18, and 24 ]

4.  Secondary:   Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This was a single-arm study and thus potential placebo effect was unable to be adjusted in any efficacy analyses.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anya Huang, Brand Physician
Organization: Astrazeneca Investment (China) Co., Ltd.
phone: +86 21 6030 2032
e-mail: anya.huang@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01608724     History of Changes
Other Study ID Numbers: D1680L00008
Study First Received: May 28, 2012
Results First Received: May 14, 2015
Last Updated: December 31, 2015
Health Authority: China: Ethics Committee