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Safety and Efficacy of Dapagliflozin 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:
NCT01646320
First received: July 18, 2012
Last updated: May 18, 2016
Last verified: May 2016
Results First Received: March 9, 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: Dapagliflozin
Drug: Placebo matching with Dapagliflozin
Drug: Saxagliptin
Drug: Metformin immediate release (IR)

  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
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial with Dapagliflozin added to Saxagliptin in Combination with Metformin compared to placebo added to Saxagliptin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and Saxagliptin

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR

Arm 2: Placebo + Saxagliptin + Metformin IR


Reporting Groups
  Description
Dapa+Saxa+Met Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
Pla+Saxa+Met Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks

Participant Flow for 2 periods

Period 1:   Short-term Period (Day 1 to Week 24)
    Dapa+Saxa+Met     Pla+Saxa+Met  
STARTED     160     160  
COMPLETED     148     153  
NOT COMPLETED     12     7  
Adverse Event                 3                 0  
No longer meets study criteria                 0                 1  
Not reported                 2                 2  
Not specified                 1                 0  
Lost to Follow-up                 4                 4  
Withdrawal by Subject                 2                 0  

Period 2:   Long-term Period (Weeks 24 to 52)
    Dapa+Saxa+Met     Pla+Saxa+Met  
STARTED     147     147  
COMPLETED     141     140  
NOT COMPLETED     6     7  
Subject no longer meets study criteria                 2                 0  
Withdrawal by Subject                 0                 2  
Adverse Event                 4                 2  
Lack of Efficacy                 0                 1  
Lost to Follow-up                 0                 2  



  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.
All randomized subjects who received at least one dose of study medication

Reporting Groups
  Description
Dapa+Saxa+Met Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
Pla+Saxa+Met Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
Total Total of all reporting groups

Baseline Measures
    Dapa+Saxa+Met     Pla+Saxa+Met     Total  
Number of Participants  
[units: participants]
  160     160     320  
Age  
[units: YEARS]
Mean (Standard Deviation)
  55.2  (8.61)     55.0  (9.60)     55.1  (9.10)  
Age, Customized  
[units: Participants]
     
< 65 years     137     132     269  
>= 65 years     23     28     51  
Gender  
[units: Participants]
     
Female     90     84     174  
Male     70     76     146  
Race/Ethnicity, Customized  
[units: Participants]
     
ASIAN     1     1     2  
BLACK/AFRICAN AMERICAN     8     10     18  
OTHER     1     2     3  
WHITE     150     147     297  
AMERICAN INDIAN/ALASKA NATIVE     0     0     0  
NATIVE HAWAIIAN/OTHER PACIFIC ISLANDER     0     0     0  



  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 Fasting Plasma Glucose at Week 24   [ Time Frame: From Baseline to Week 24 ]

3.  Secondary:   Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24   [ Time Frame: From Baseline to Week 24 ]

4.  Secondary:   Adjusted Mean Change From Baseline in Body Weight at Week 24   [ Time Frame: From baseline to Week 24 ]

5.  Secondary:   Percentage of Subjects 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 762 484
e-mail: Eva.Johnsson@astrazeneca.com


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01646320     History of Changes
Other Study ID Numbers: MB102-129
2011-006324-20 ( EudraCT Number )
Study First Received: July 18, 2012
Results First Received: March 9, 2016
Last Updated: May 18, 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