At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 478 enrolled
Drug / intervention
MYL-1601D Product +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.
A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D With NovoLog® in Type 1 Diabetes Mellitus Patients
In Brief
A Phase 3 clinical trial evaluating MYL-1601D Product and FlexPen NovoLog® for Diabetes Mellitus, Type 1. Completed, enrolled 478 participants across 158 sites.
Detailed Summary
The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy profile between MYL-1601D and NovoLog® in patients with T1DM.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
CollaboratorsMylan GmbH
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartNov 2018
First PostedNov 2018
Primary CompletionDec 2019
Study CompletionJan 2020
TodayJul 2026
First PostedNov 30, 2018
Enrollment StartNov 7, 2018
Primary CompletionDec 28, 2019
Study CompletionJan 17, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.6 years ago
Interventions
MYL-1601D Productdrug
(100 U/mL)
FlexPen NovoLog®drug
(100 U/mL)