Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

• Register: EUCTR
• Last refreshed on: 24 June 2013
• Main ID: EUCTR2009-017358-10-HU
• Date of registration: 15/02/2010
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
• Scientific title: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus 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 - SAVOR
• Date of first enrolment: 26/03/2010
• Target sample size: 16500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017358-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Argentina, Australia, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Mexico, Netherlands, Peru, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States

Contacts

• Name: Information Centre
• Affiliation: AstraZeneca

• Name: Information Centre
• Affiliation: AstraZeneca

Key inclusion & exclusion 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics

Acute vascular event <2months prior to randomisation



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus
MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Product Name: Saxagliptin
Product Code: BMS-477118-11
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Saxagliptin
CAS Number: 945667-22-1
Current Sponsor code: BMS-477118-11
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Saxagliptin
Product Code: BMS-477118-11
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: saxagliptin
CAS Number: 945667-22-1
Current Sponsor code: BMS-477118-11
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: The first secondary efficacy objective is to determine whether treatment with saxagliptin compared with placebo when added to current background therapy in patients with T2DM will result in a reduction of the composite endpoint of CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris or
hospitalisation for coronary revascularisation.
The next secondary efficacy objective is to determine whether treatment with saxagliptin compared with placebo when added to current background therapy in patients with type 2 diabetes mellitus will result in a reduction of all-cause mortality.

Primary end point(s): The primary efficacy and 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 to first event).

Main Objective: The primary efficacy objective is to determine, as a superiority assessment, whether treatment with saxagliptin compared with placebo when added to current background therapy will result in a reduction in the composite endpoint of CV death, non-fatal MI or non-fatal ischaemic stroke in patients with T2DM.
The primary safety objective is to establish that the upper bound of the 2-sided 95% CI for the estimated risk ratio comparing the incidence of the composite endpoint of CV death, non-fatal MI or non-fatal ischaemic stroke in patients with T2DM observed with saxagliptin to that observed in the placebo group is less than 1.3.

Timepoint(s) of evaluation of this end point: End of study, once 1040 Major adverse cardiovascular events (MACE) events are accrued

Secondary Outcome(s)

Secondary end point(s): The secondary efficacy variable is the composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris or hospitalisation for coronary revascularisation.

Timepoint(s) of evaluation of this end point: End of study, once 1040 Major adverse cardiovascular events (MACE) events are accrued

Secondary ID(s)

NCT01107886

D1680C00003

Source(s) of Monetary Support

AstraZeneca AB

Bristol-Myers Squibb Pharmaceuticals Ltd