Dapagliflozin DPPIV Inhibitor add-on Study
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|ClinicalTrials.gov Identifier: NCT00984867|
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : October 14, 2013
Last Update Posted : June 13, 2014
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|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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with type 2 diabetes
- Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
- Patients will be screened by a blood test and only those who need additional therapy can be enrolled
- Patients with type 1 diabetes
- Patients with very poorly controlled diabetes
- Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study
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|
Publications of Results:
|Other Study ID Numbers:||
|First Posted:||September 25, 2009 Key Record Dates|
|Results First Posted:||October 14, 2013|
|Last Update Posted:||June 13, 2014|
|Last Verified:||June 2014|
Dapagliflozin DPP IV inhibitor add on study
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs