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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01107886
First received: March 25, 2010
Last updated: July 9, 2014
Last verified: July 2014
  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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact —whichever was later.


Enrollment: 18206
Study Start Date: May 2010
Study Completion Date: May 2013
Primary Completion Date: May 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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Research Site
Örebro, Sweden
Research Site
Östersund, Sweden
Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Kaohsiung Hsien, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Research Site
Yong-Kang City, Taiwan
Thailand
Research Site
Bangkok, Thailand
Research Site
Bangkoknoi, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Ratchaburi, Thailand
United Kingdom
Research Site
Aylesbury, United Kingdom
Research Site
Bath, United Kingdom
Research Site
Belfast, United Kingdom
Research Site
Blackpool, United Kingdom
Research Site
Corsham, United Kingdom
Research Site
Coventry, United Kingdom
Research Site
Fowey, United Kingdom
Research Site
Kenton, United Kingdom
Research Site
Leicester, United Kingdom
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Mortimer Reading, United Kingdom
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Plymouth, United Kingdom
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Sheffield, United Kingdom
Research Site
Sunbury on Thames, United Kingdom
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Swindon, United Kingdom
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Wansford, United Kingdom
Research Site
Warminster, United Kingdom
Research Site
Whitstable, 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

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: May 15, 2014
Last Updated: July 9, 2014
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 Pública 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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on September 11, 2014