Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea
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ClinicalTrials.gov Identifier: NCT01392677 |
Recruitment Status
:
Completed
First Posted
: July 12, 2011
Results First Posted
: December 27, 2013
Last Update Posted
: March 12, 2014
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Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
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Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions: |
Type 2 Diabetes Mellitus High HbA1c Level Inadequate Glycaemic Control |
Interventions: |
Drug: dapagliflozin Drug: placebo |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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First participant enrolled: 24 Oct 2011. Last participant completed 24 week period: 07 Jan 2013. 311 participants were enrolled, 219 were randomized in 45 centers in 5 European countries and in North America. Men and women aged >= 18 years with inadequate glycemic control (HbA1c 7.0% to 10.5% prior to randomization). |
Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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During enrollment, diet and life-style advice was given to participants and was reinforced during a placebo lead-in period. Dose of anti-hyperglycemic combination therapy of metformin >= 1500 mg/day and maximum tolerated dose which must be at least half the maximum dose of sulfonylurea for at least 8 weeks prior to enrollment were to remain stable. |
Reporting Groups
Description | |
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Placebo Plus Metformin Plus Sulfonylurea | Placebo once daily plus background combination of metformin and sulfonylurea |
Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea |
Participant Flow: Overall Study
Placebo Plus Metformin Plus Sulfonylurea | Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | |
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STARTED | 109 | 109 |
COMPLETED | 101 | 101 |
NOT COMPLETED | 8 | 8 |
Adverse Event | 3 | 1 |
Withdrawal by Subject | 0 | 2 |
Incorrect enrollment | 2 | 3 |
Other reason | 3 | 2 |

1. Primary: | Adjusted Mean Change From Baseline in HbA1c Levels [ Time Frame: Baseline to week 24 ] |
2. Secondary: | Adjusted Mean Change From Baseline in FPG [ Time Frame: Baseline to week 24 ] |
3. Secondary: | Adjusted Mean Change From Baseline in Total Body Weight [ Time Frame: Baseline to week 24 ] |
4. Secondary: | Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF) [ Time Frame: Baseline to week 24 ] |
5. Secondary: | Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure [ Time Frame: Baseline to week 8 ] |

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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For participants who did not complete 8 and/or 24 weeks, respectively, last observation carried forward (LOCF) was used for analyses of secondary endpoints. All endpoints were evaluated by excluding data after rescue. |

Certain Agreements:
Results Point of Contact:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS 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. | ||||||
The agreement is:
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Results Point of Contact:
Name/Title: Eva Johnsson
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com
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: | NCT01392677 History of Changes |
Other Study ID Numbers: |
D1693C00005 |
First Submitted: | July 11, 2011 |
First Posted: | July 12, 2011 |
Results First Submitted: | November 5, 2013 |
Results First Posted: | December 27, 2013 |
Last Update Posted: | March 12, 2014 |