At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 574 enrolled
Drug / intervention
Linagliptin +6 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.
An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug
In Brief
A Phase 3 clinical trial evaluating Linagliptin and Metformin for Diabetes Mellitus, Type 2. Completed, enrolled 574 participants across 43 sites.
Detailed Summary
The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesJapan
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedSep 2010
Primary CompletionJan 2012
TodayJul 2026
First PostedSep 17, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.8 years ago
Interventions
Linagliptindrug
Linagliptin once daily
Linagliptindrug
Linagliptin once daily
Metformindrug
Metformin twice or three time per day
Metformindrug
Metformin twice or three time per day
Linagliptindrug
Linagliptin once daily
Linagliptindrug
Linagliptin once daily
Linagliptindrug
Linagliptin once daily