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Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01619059
First received: June 12, 2012
Last updated: March 24, 2016
Last verified: March 2016
Results First Received: February 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Saxagliptin
Drug: Dapagliflozin
Drug: Metformin IR
Drug: Placebo matching with 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
Of 315 participants randomized, 298 completed Short-Term (ST) treatment period. Of 297 participants entered Long-Term (LT) treatment period, 280 completed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo + Dapagliflozin 10mg + Metformin Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
Saxagliptin 5mg + Dapagliflozin 10mg + Metformin Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks

Participant Flow for 2 periods

Period 1:   Short-Term (ST) Treatment Period
    Placebo + Dapagliflozin 10mg + Metformin     Saxagliptin 5mg + Dapagliflozin 10mg + Metformin  
STARTED     162     153  
COMPLETED     156     142  
NOT COMPLETED     6     11  
Adverse Event                 1                 0  
Withdrawal by Subject                 2                 5  
Lost to Follow-up                 2                 4  
Non-compliance, not Met Study Criteria                 1                 2  

Period 2:   Long-Term (LT) Treatment Period
    Placebo + Dapagliflozin 10mg + Metformin     Saxagliptin 5mg + Dapagliflozin 10mg + Metformin  
STARTED     155     142  
COMPLETED     147     133  
NOT COMPLETED     8     9  
Lack of Efficacy                 0                 1  
Adverse Event                 2                 3  
Withdrawal by Subject                 3                 2  
Death                 1                 0  
Lost to Follow-up                 2                 2  
Not Met Study Criteria                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Placebo + Dapagliflozin 10mg + Metformin Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
Saxagliptin 5mg + Dapagliflozin 10mg + Metformin Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo + Dapagliflozin 10mg + Metformin     Saxagliptin 5mg + Dapagliflozin 10mg + Metformin     Total  
Number of Participants  
[units: participants]
  162     153     315  
Age  
[units: YEARS]
Mean (Standard Deviation)
  54.5  (9.32)     54.7  (9.83)     54.6  (9.56)  
Age, Customized  
[units: Participants]
     
< 65     140     132     272  
>= 65     22     21     43  
Gender  
[units: Participants]
     
Female     86     80     166  
Male     76     73     149  
Race/Ethnicity, Customized  
[units: Participants]
     
AMERICAN INDIAN/ALASKA NATIVE     2     0     2  
ASIAN     8     5     13  
BLACK/AFRICAN AMERICAN     9     11     20  
OTHER     2     1     3  
WHITE     141     136     277  



  Outcome Measures
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1.  Primary:   Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24   [ Time Frame: From Baseline to Week 24 ]

2.  Secondary:   Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24   [ Time Frame: From Baseline to Week 24 ]

3.  Secondary:   Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24   [ Time Frame: From Baseline to Week 24 ]

4.  Secondary:   Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline to 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
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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.


Results Point of Contact:  
Name/Title: Eva Johnsson, Clinical Science Lead
Organization: AstraZeneca Pharmaceuticals
phone: +46 31 7762484 ext 762484
e-mail: Eva.Johnsson@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01619059     History of Changes
Other Study ID Numbers: CV181-168
2011-006323-37 ( EudraCT Number )
Study First Received: June 12, 2012
Results First Received: February 18, 2016
Last Updated: March 24, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks