Trial record 1 of 10 for:
saxagliptin cardiovascular
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:
AstraZeneca
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
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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:
- 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
Show 531 Study Locations
Show 531 Study LocationsSponsors 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):
| 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:
|
Cardiovascular Diseases Saxagliptin Diabetes Mellitus Diabetes Mellitus, Type 2 Myocardial Infarction Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Myocardial Ischemia |
Heart Diseases Vascular Diseases 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 21, 2013