CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 560 enrolled
Drug / intervention
Mylan's insulin glargine +1 moredrug
Likely dose
Mylan's insulin glargine 10 unitsfrom 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/NCT02227875
NCT02227875Phase 3Completed
CompareCT.gov

An Open-label, Randomized, Multi-center, Parallel Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients

Mylan Inc.·interventional·Posted Aug 28, 2014·Updated Mar 3, 2022

In Brief

A Phase 3 clinical trial evaluating Mylan's insulin glargine and Lantus® for Type 2 Diabetes. Completed, enrolled 560 participants across 120 sites in 6 countries.

Detailed Summary

To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline to 24 weeks

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesJordan, Slovakia, South Africa, South Korea, Taiwan, United States
CollaboratorsMylan GmbH

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 28, 2014
Enrollment StartAug 1, 2014
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.8 years ago

Interventions

Mylan's insulin glarginedrug

Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

Lantus®drug

For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.