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

Sponsor: AstraZeneca

 Purpose
 

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

 

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

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