At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 127 enrolled
Drug / intervention
Mylan's insulin glargine +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.
An Open-label, Randomized, Multi-center, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients: An Extension Study
In Brief
A Phase 3 clinical trial evaluating Mylan's insulin glargine and Lantus® for Type 1 Diabetes Mellitus. Completed, enrolled 127 participants across 81 sites in 8 countries.
Detailed Summary
The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesCanada, Czechia, Estonia, Germany, Hungary, Latvia, Slovakia, United States
CollaboratorsMylan GmbH
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedJan 2016
Primary CompletionMar 2017
Study CompletionJul 2017
TodayJul 2026
First PostedJan 28, 2016
Enrollment StartDec 1, 2015
Primary CompletionMar 1, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.4 years ago
Interventions
Mylan's insulin glarginedrug
Lantus®drug