At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 18,206 enrolled
Drug / intervention
Saxagliptin +1 moredrug
Likely dose
Saxagliptin 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Saxagliptin and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 18,206 participants across 536 sites in 27 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesArgentina, Australia, Brazil, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Mexico, Netherlands, Peru, Poland, Puerto Rico, Russia, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartMay 2010
Primary CompletionMay 2013
TodayJul 2026
First PostedApr 21, 2010
Enrollment StartMay 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.2 years ago
Interventions
Saxagliptindrug
5 mg or 2.5 mg once daily
Placebodrug