CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,122 enrolled
Drug / intervention
linagliptine 5 mg +1 moredrug
Likely dose
linagliptine 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.

Search/NCT00736099
NCT00736099Phase 3Completed
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A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.

Boehringer Ingelheim·interventional·Posted Aug 15, 2008·Updated Jun 27, 2014

In Brief

A Phase 3 clinical trial evaluating linagliptine 5 mg and linagliptine 5 mg and pioglitazone 30 mg for Diabetes Mellitus, Type 2. Completed, enrolled 2,122 participants across 232 sites in 32 countries.

Detailed Summary

The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment. The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Austria, Belgium, Canada, China, Croatia, Czechia, Finland, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 15, 2008
Enrollment StartAug 1, 2008
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.9 years ago

Interventions

linagliptine 5 mgdrug

safety and efficacy of linagliptine 5 mg open label

linagliptine 5 mg and pioglitazone 30 mgdrug

efficacy and safety of the combination linagliptine and pioglitazone