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Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Astra Zeneca, Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00831779
First received: January 28, 2009
Last updated: January 10, 2017
Last verified: January 2017
Results First Received: September 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
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 116 participants enrolled, 50 completed a qualification period. Of these 50 participants, 44 were randomized and received treatment. Of these 44 participants, 42 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 + Background Anti-Diabetes Medication Placebo tablets, oral, once daily, 12 weeks
Dapagliflozin 5 mg + Background Anti-Diabetes Medication Dapagliflozin tablets, oral, once daily, 12 weeks

Participant Flow:   Overall Study
    Placebo + Background Anti-Diabetes Medication   Dapagliflozin 5 mg + Background Anti-Diabetes Medication
STARTED   21   23 
COMPLETED   20   22 
NOT COMPLETED   1   1 
Lost to Follow-up                1                0 
No longer met 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.
All randomized participants who received at least 1 dose of study medication

Reporting Groups
  Description
Placebo + Background Anti-Diabetes Medication Placebo tablets, oral, once daily, 12 weeks
Dapagliflozin 5 mg + Background Anti-Diabetes Medication Dapagliflozin tablets, oral, once daily, 12 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo + Background Anti-Diabetes Medication   Dapagliflozin 5 mg + Background Anti-Diabetes Medication   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   23   44 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.3  (8.02)   56.2  (8.85)   54.8  (8.49) 
Age, Customized 
[Units: Participants]
     
Younger than 65 years   18   19   37 
65-70 years   3   4   7 
Gender, Customized 
[Units: Participants]
     
Male   14   15   29 
Female   7   8   15 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   15   13   28 
Black/African American   6   9   15 
Asian   0   1   1 


  Outcome Measures
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1.  Primary:   Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline to Week 12 ]

2.  Secondary:   Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline to Week 12 ]


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



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00831779     History of Changes
Other Study ID Numbers: MB102-045
Study First Received: January 28, 2009
Results First Received: September 30, 2016
Last Updated: January 10, 2017