Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (SAVOR- TIMI 53)
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|ClinicalTrials.gov Identifier: NCT01107886|
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : June 13, 2014
Last Update Posted : July 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Saxagliptin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
5 mg or 2.5 mg once daily
Other Name: Onglyza
Placebo Comparator: Placebo
- Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke [ Time Frame: Randomization (day 0) up to 2.9 years ]Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)—whichever was later.
- Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation [ Time Frame: Randomization (day 0) up to 2.9 years ]Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)—whichever was later.
- Participants With Event of Death [ Time Frame: Randomization (day 0) up to 2.9 years ]Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact —whichever was later.
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): NCT01107886
Show 551 Study Locations
|Study Chair:||Eugene Braunwald||TIMI|
|Principal Investigator:||Itamar Raz||hadassah medical organisation|
|Principal Investigator:||Deepak Bhatt||TIMI|