At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 133 enrolled
Drug / intervention
Insulin Glargine Ezelin +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.
Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients
In Brief
A Phase 2 clinical trial evaluating Insulin Glargine Ezelin and Insulin Glargine Pen Injector [Lantus] for Diabetes Mellitus. Completed, enrolled 133 participants across 1 site.
Detailed Summary
This is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes mellitus patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesIndonesia
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartSep 2016
First PostedNov 2017
Primary CompletionDec 2018
TodayJul 2026
First PostedNov 24, 2017
Enrollment StartSep 1, 2016
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.6 years ago
Interventions
Insulin Glargine Ezelindrug
Insulin Glargine (Ezelin) once daily at individually adjusted dose
Insulin Glargine Pen Injector [Lantus]drug
Insulin Glargine (Lantus) once daily at individually adjusted dose