Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (SAVOR- TIMI 53)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01107886

First received: March 25, 2010

Last updated: November 19, 2012

Last verified: November 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Saxagliptin Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Heart Attack

Drug Information available for: Saxagliptin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary efficacy outcome variable of the study is defined as the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke [ Time Frame: Time to first event. Information collected during study period (anticipated to be 4 years). ] [ Designated as safety issue: No ]
The primary safety outcome variable of the study is defined as the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke [ Time Frame: Time to first event. Information collected during study period (anticipated to be 4 years). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal ischaemic stroke, hospitalisation for heart failure, unstable angina pectoris or coronary revascularisation [ Time Frame: Time to first event. Information collected during study period (anticipated to be 4 years). ] [ Designated as safety issue: No ]
The next secondary efficacy variable is any documented death [ Time Frame: Time to event. Information collected during study period (anticipated to be 4 years) ] [ Designated as safety issue: No ]

Enrollment:	16500
Study Start Date:	May 2010
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with type 2 diabetes mellitus
HbA1c ≥6.5%. (based on the last measured and documented laboratory measurement within 6 months)
High risk for CV events -Established cardiovascular disease and/or multiple risk factors

Exclusion Criteria:

Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
Acute vascular event <2months prior to randomisation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107886

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Reading, Berks, United Kingdom
Research Site
Aylesbury, Bucks, United Kingdom
Research Site
Fowey, Cornwall, United Kingdom
Research Site
Plymouth, Devon, United Kingdom
Research Site
Whitstable, Kent, United Kingdom
Research Site
Burbage, Leicester, United Kingdom
Research Site
Kenton, Middlesex, United Kingdom
Research Site
Sunbury on Thames, Middlesex, United Kingdom
Research Site
Belfast, N. Ireland, United Kingdom
Research Site
Wansford, Peterborough, United Kingdom
Research Site
Ecclesfield, Sheffield, United Kingdom
Research Site
Corsham, Wiltshire, United Kingdom
Research Site
Warminster, Wiltshire, United Kingdom
Research Site
Bath, United Kingdom
Research Site
Blackpool, United Kingdom
Research Site
Coventry, United Kingdom
Research Site
Swindon, United Kingdom

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Study Chair:	Eugene Braunwald	TIMI
Principal Investigator:	Itamar Raz	Hadassah Medical Organisation
Principal Investigator:	Deepak Bhatt	TIMI

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Price DL, Chen R, Udell J, Raz I. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 Nov;162(5):818-825.e6.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01107886 History of Changes
Other Study ID Numbers:	D1680C00003, EudraCT No 2009-017358-10
Study First Received:	March 25, 2010
Last Updated:	November 19, 2012
Health Authority:	Argentina: Ministry of Health Australia: Department of Health and Ageing Therapeutic Goods Administration Brazil: Ministry of Health Canada: Health Canada Chile: Instituto de Salud Publica de Chile China: Food and Drug Administration Czech Republic: State Institute for Drug Control France: Ministry of Health Germany: Ethics Commission Hungary: National Institute of Pharmacy India: Drugs Controller General of India Israel: Ministry of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Mexico: Federal Commission for Protection Against Health Risks Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Peru: Instituto Nacional de Salud Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation South Africa: Medicines Control Council Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency Taiwan: Department of Health Thailand: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Risk of cardiovascular disease and death in patients with type 2 diabetes mellitus

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Myocardial Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013

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