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18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00666458
First received: April 23, 2008
Last updated: March 5, 2010
Last verified: March 2010
History of Changes
Results First Received: March 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: saxagliptin
Drug: sitagliptin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Saxa + Met Saxagliptin 5 mg tablets added on to open-label metformin
Sita + Met Sitagliptin 100 mg capsules added on to open-label metformin

Participant Flow:   Overall Study
    Saxa + Met     Sita + Met  
STARTED     403 [1]   398 [1]
COMPLETED     365 [2]   374 [2]
NOT COMPLETED     38     24  
Adverse Event                 8                 7  
Withdrawal by Subject                 5                 4  
Lost to Follow-up                 0                 3  
Administrative reason by sponsor                 1                 1  
Incorrect enrollment                 7                 1  
Study specific discontinuation criteria                 14                 7  
Severe non-compliance to the protocol                 1                 1  
Safety reasons                 1                 0  
Medical history of anemia                 1                 0  
[1] Randomized and treated
[2] Completed 18 weeks of treatment



  Baseline Characteristics
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Reporting Groups
  Description
Saxa + Met Saxagliptin 5 mg tablets added on to open-label metformin
Sita + Met Sitagliptin 100 mg capsules added on to open-label metformin
Total Total of all reporting groups

Baseline Measures
    Saxa + Met     Sita + Met     Total  
Number of Participants  
[units: participants]
 		  403     398     801  
Age  
[units: years]
Mean ± Standard Deviation 		  58.77  ± 10.14     58.07  ± 10.51     58.42  ± 10.32  
Gender  
[units: Participants]
 		     
Female     213     196     409  
Male     190     202     392  



  Outcome Measures
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1.  Primary:   Hemoglobin A1c (HbA1c) Change From Baseline to Week 18   [ Time Frame: Baseline, Week 18 ]
  Show Outcome Measure 1

2.  Secondary:   Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18   [ Time Frame: Week 18 (Last Observation Carried Forward) ]
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3.  Secondary:   Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)   [ Time Frame: Baseline, Week 18 (Last Observation Carried Forward) ]
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4.  Secondary:   Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)   [ Time Frame: Baseline, Week 18 (Last Observation Carried Forward) ]
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Measure Type Secondary
Measure Title Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)
Measure Description Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Time Frame Baseline, Week 18 (Last Observation Carried Forward)  
Safety Issue No  

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.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.

Reporting Groups
  Description
Saxa + Met Saxagliptin 5 mg tablets added on to open-label metformin
Sita + Met Sitagliptin 100 mg capsules added on to open-label metformin

Measured Values
    Saxa + Met     Sita + Met  
Number of Participants Analyzed  
[units: participants]
 		  397     392  
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)  
[units: mmol/L]
Mean ± Standard Error 		   
Baseline     8.86  ± 0.127     8.89  ± 0.122  
Week 18     8.27  ± 0.111     7.99  ± 0.103  
Adjusted Change from Baseline     -0.60  ± 0.081     -0.90  ± 0.081  


Statistical Analysis 1 for Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)
Groups [1] All groups
Mean Difference (Net) [2] 0.30
Standard Error of the mean ± 0.115
95% Confidence Interval ( 0.08 to 0.53 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.




  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
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: Peter Öhman, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00666458     History of Changes
Other Study ID Numbers: D1680C00002, EudraCT number 2007-006095-11
Study First Received: April 23, 2008
Results First Received: March 5, 2010
Last Updated: March 5, 2010
Health Authority: Sweden: The National Board of Health and Welfare
Norway: Norwegian Institute of Public Health
Denmark: National Board of Health
Italy: National Institute of Health
France: Direction Générale de la Santé
South Africa: Department of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Ministry of Health
Mexico: Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP