Phase 4
Completed N=16,492
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
Source: ClinicalTrials.gov NCT01107886 ↗Enrolled (actual)
16,492
Serious AEs
25.4%
Results posted
Jun 2014
Primary outcomePrimary: Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke — 613; 609 participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke |
613; 609 | — |
| SECONDARY Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation |
1059; 1034 | — |
| SECONDARY Participants With Event of Death |
420; 378 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01107886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.