At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 6,991 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in 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.
CARMELINA: A Multicenter, International, Randomized, Parallel Group, Double-blind, Placebo-controlled, Cardiovascular Safety and Renal Microvascular Outcome Study With Linagliptin, 5 mg Once Daily in Patients With Type 2 Diabetes Mellitus at High Vascular Risk
In Brief
A Phase 4 clinical trial evaluating Placebo and Linagliptin for Diabetes Mellitus, Type 2. Completed, enrolled 6,991 participants across 649 sites in 27 countries.
Detailed Summary
The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a background of standard of care.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Germany, Hungary, Israel, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedJul 2013
Primary CompletionJan 2018
TodayJul 2026
First PostedJul 12, 2013
Enrollment StartJul 10, 2013
Primary CompletionJan 18, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.0 years ago
Interventions
Placebodrug
placebo matching tablets
Linagliptindrug