At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 241 enrolled
Drug / intervention
linagliptin +1 moredrug
Likely dose
linagliptin 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 Phase III Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Linagliptin (5 mg) Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients (Age >= 70 Years) With Insufficient Glycaemic Control( HbA1c >= 7.0) Despite Metformin and/or Sulphonylurea and/or Insulin Therapy
In Brief
A Phase 3 clinical trial evaluating linagliptin and placebo for Diabetes Mellitus, Type 2. Completed, enrolled 241 participants across 34 sites in 5 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 given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustralia, Canada, Denmark, Netherlands, Sweden
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionJun 2011
TodayJul 2026
First PostedMar 10, 2010
Enrollment StartMar 1, 2010
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.3 years ago
Interventions
linagliptindrug
patients receive linagliptin 5 mg tablets once daily
placebodrug
patients receive placebo matching linagliptin 5 mg once daily