At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,263 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.
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of Linagliptin (5 mg), Administered Orally Once Daily for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy
In Brief
A Phase 3 clinical trial evaluating Placebo and Linagliptin for Diabetes Mellitus, Type 2. Completed, enrolled 1,263 participants across 169 sites in 19 countries.
Detailed Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Belgium, Brazil, Canada, Czechia, Finland, Germany, Greece, Italy, Mexico, Netherlands, Norway, Peru, Russia, Slovakia, South Korea, Spain, Taiwan, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedAug 2009
Primary CompletionSep 2011
TodayJul 2026
First PostedAug 7, 2009
Enrollment StartAug 1, 2009
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.9 years ago
Interventions
Placebodrug
Placebo, identical to Linagliptin tablet
Linagliptindrug
intended final marketed dose