At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 219 enrolled
Drug / intervention
MYL-1501D product using manufacture process V +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, Multi-center, Double-Blind, Parallel-Group Clinical Study Comparing the Efficacy and Safety of MYL-1501D Produced by Two Manufacturing Processes in Type 1 Diabetes Mellitus Patients
In Brief
A Phase 3 clinical trial evaluating MYL-1501D product using manufacture process V and MYL-1501D product using manufacture process VI for Diabetes Mellitus, Type 1. Completed, enrolled 219 participants across 38 sites.
Detailed Summary
The aim of this study is to demonstrate similar efficacy and safety between MYL-1501D products produced from two manufacturing processes (Process V and Process VI) in combination with insulin lispro in patients with type 1 diabetes mellitus (T1DM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
CollaboratorsMylan GmbH
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartNov 2017
First PostedDec 2017
Primary CompletionSep 2018
Study CompletionJan 2019
TodayJul 2026
First PostedDec 18, 2017
Enrollment StartNov 29, 2017
Primary CompletionSep 25, 2018
Study CompletionJan 10, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.5 years ago
Interventions
MYL-1501D product using manufacture process Vdrug
MYL-1501D product using manufacture process V
MYL-1501D product using manufacture process VIdrug
MYL-1501D product using manufacture process VI