Dapagliflozin DPPIV Inhibitor add-on Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00984867|
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : October 14, 2013
Last Update Posted : June 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Dapagliflozin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||833 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||September 2011|
Active Comparator: 1
Dapagliflozin 10 mg tablet
10 mg tablet, oral, once daily, 48 weeks
Placebo Comparator: 2
Matching placebo tablet
Matching placebo tablet
- Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 24 ]To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.
- Adjusted Mean Change in Body Weight [ Time Frame: Baseline to Week 24 ]To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.
- Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8% [ Time Frame: Baseline to Week 24 ]To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.
- Adjusted Mean Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 24 ]To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.
- Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg [ Time Frame: Baseline to Week 8 ]To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8.
- Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise [ Time Frame: Baseline to Week 24 ]To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.
- Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline [ Time Frame: Baseline to Week 24 ]To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984867
|Principal Investigator:||Serge Jabbour, MD||Thomas Jefferson University, Philadelphia|