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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.

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Official Title

The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

Does saxagliptin reduce the risk of cardiovascular events when used alone or added to other diabetes medications

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

Research Site

CVD subjects were defined as subjects with history of established CV disease. MRF subjects were defined as subjects with MRF for vascular disease without established CV disease.

Cardiovascular Risk Category: Cardiovascular disease/Multiple risk factors (CVD/MRF)

Study Specific Characteristic

Renal function categories Normal function – Mild impairment defined as: eGFR >50 mL/min; Moderate impairment defined as: eGFR 30 to 50 mL/min; Severe impairment defined as: eGFR eGFR <30 mL/min.

Renal Functione Categor: Normal or Mild impairment/Moderate impairment/Severe impairment

Age Continuous

Gender, Male/Female

Race (NIH/OMB)

Ethnicity (NIH/OMB)

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.

Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.

Participants With Any Event from the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke

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 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

Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact —whichever was later.

Participants With Event of Death

Overall Study

Subjects meeting all inclusion criteria and with no exclusion criteria were randomised in a 1:1 ratio to receive either saxagliptin or matching placebo (Day 0). 

Arms	Assigned Interventions
Experimental: Saxagliptin	Drug: Saxagliptin 5 mg or 2.5 mg once daily Other Name: Onglyza
Placebo Comparator: Placebo	-

Does saxagliptin reduce the risk of cardiovascular events when used alone or added to other diabetes medications - SAVOR- TIMI 53

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

D1680C00003 Clinical Study Protocol

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1185&filename=D1680C00003_Study_Synopsis_for_CTW.pdf

D1680C00003_CSR_Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator