CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6,103 enrolled
Drug / intervention
linagliptin +3 moredrug
Likely dose
linagliptin 5mgfrom 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.

Search/NCT01243424
NCT01243424Phase 3Completed
CompareCT.gov

A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.

Boehringer Ingelheim·interventional·Posted Nov 18, 2010·Updated Jan 7, 2020

In Brief

A Phase 3 clinical trial evaluating linagliptin, glimepiride, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 6,103 participants across 613 sites in 43 countries.

Detailed Summary

The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tunisia, Ukraine, United Kingdom, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 18, 2010
Enrollment StartNov 11, 2010
Primary CompletionAug 21, 2018
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 15.6 years ago

Interventions

linagliptindrug

linagliptin tablets 5mg QD

glimepiridedrug

glimepiride over-encapsulated tablet 1-4 mg QD

linagliptin placebodrug

linagliptin placebo

glimepiride placebodrug

glimepiride placebo