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

Sponsor: AstraZeneca


 Purpose
 

ConditionInterventionPhase
Type 2 Diabetes MellitusDrug: Saxagliptin
Drug: Placebo
Phase IV

 
ArmsAssigned Interventions
Saxagliptin: ExperimentalDrug: Saxagliptin
5 mg or 2.5 mg once daily
Placebo: Placebo ComparatorDrug: 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

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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

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Contacts

Physicians:
Ameer Kabour, MD
Tarif Kanaan, MD

Coordinators:
Michelle Hickam, RN, BSN
Brenda Hoagland, RN, CCRC
Julie Neidhardt, RN, BSN

Please contact us at 419-251-4919 for further information about this study.

Source: ClinicalTrials.gov
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