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 whith Type 2 Diabetes

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 whith Type 2 Diabetes - SAVOR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36559

Enrollment

600

Registered

2010-05-18

Start date

2010-07-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

Patients meeting all eligibility criteria will be randomised (1:1) to receive either saxagliptin or placebo. Active treatment will comprise the doses of 5 and 2.5 mg based upon a patient*s renal fun

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -age * 40 years -diagnosed with T2DM based on the current ADA guidelines -HbA1c *6.5% -high risk for a CV event defined as having either established CV disease and/or multiple risk factors

Exclusion criteria

Exclusion criteria: -current or previous (within 6 months) treatment with an incretin-based therapy such as DPP4 inhibitors and or GLP-1 mimetics -acute vascular (cardiac or stroke) event 6.0 mg/dL (> 530 µmol/L) -pregnant or breast-feeding patients

Design outcomes

Primary

Measure	Time frame
Primary efficacy variable 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 to first event). Primary safety variable 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 to first event).	—

Measure

Time frame

Primary efficacy variable 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 to first event). Primary safety variable 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 to first event).

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Secondary

Measure	Time frame
Secondary efficacy variable 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. Secondary safety variables Secondary safety variables includes overall adverse events and adverse events of special interest. These will include assessment of the long-term effects of saxagliptin on decrease in lymphocyte counts, decrease in thrombocyte counts, severe infections, hypersensitivity reactions, liver abnormalities, bone fractures, pancreatitis, skin reactions and renal abnormalities	—

Measure

Time frame

Secondary efficacy variable 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. Secondary safety variables Secondary safety variables includes overall adverse events and adverse events of special interest. These will include assessment of the long-term effects of saxagliptin on decrease in lymphocyte counts, decrease in thrombocyte counts, severe infections, hypersensitivity reactions, liver abnormalities, bone fractures, pancreatitis, skin reactions and renal abnormalities

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)