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Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00663260
First received: April 18, 2008
Last updated: December 20, 2016
Last verified: December 2016
Results First Received: September 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Dapagliflozin
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
Of 631 participants enrolled, 276 completed a qualification period. Of these 276 participants, 252 were randomized and received treatment. Of these 252 participants, 204 completed double-blind treatment period.

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
Placebo Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
Dapagliflozin 5 mg Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
Dapagliflozin 10 mg Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)

Participant Flow:   Overall Study
    Placebo   Dapagliflozin 5 mg   Dapagliflozin 10 mg
STARTED   84   83   85 
COMPLETED   63   72   69 
NOT COMPLETED   21   11   16 
Lack of Efficacy                2                0                0 
Adverse Event                12                7                6 
Withdrawal by Subject                3                1                6 
Death                1                0                1 
Lost to Follow-up                0                1                0 
non-compliance, not met criteria, etc.                3                2                3 



  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 participants who received at least 1 dose of study medication

Reporting Groups
  Description
Placebo Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
Dapagliflozin 5 mg Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
Dapagliflozin 10 mg Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
Total Total of all reporting groups

Baseline Measures
   Placebo   Dapagliflozin 5 mg   Dapagliflozin 10 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 84   83   85   252 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (8.6)   66  (8.9)   68  (7.7)   67  (8.4) 
Age, Customized 
[Units: Participants]
       
Younger than 65 years   36   39   29   104 
65 years and older   48   44   56   148 
Gender, Customized 
[Units: Participants]
       
Male   53   55   56   164 
Female   31   28   29   88 
Race/Ethnicity, Customized 
[Units: Participants]
       
WHITE   69   65   77   211 
BLACK OR AFRICAN AMERICAN   1   7   4   12 
ASIAN   6   4   3   13 
OTHER   8   7   1   16 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 89.61  (20.046)   95.23  (20.909)   93.25  (17.309)   92.69  (19.529) 
Pre-Enrollment Anti-Hyperglycemic Therapy 
[Units: Participants]
       
INSULIN-BASED REGIMEN   55   54   55   164 
SULFONYLUREA-BASED REGIMEN   21   21   21   63 
THIAZOLIINEDIONE-BASED REGIMEN   1   1   2   4 
OTHER REGIMEN   7   7   7   21 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]   [ Time Frame: From Baseline to Week 24 ]

2.  Secondary:   Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline to Week 24 ]

3.  Secondary:   Adjusted Mean Change From Baseline in Total Body Weight (kg) 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
No text entered.


  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: Anna Maria Langkilde
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00663260     History of Changes
Other Study ID Numbers: MB102-029
Study First Received: April 18, 2008
Results First Received: September 28, 2016
Last Updated: December 20, 2016