NCT03760068

Mylan Insulin Aspart Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, open-label, randomized, parallel-group phase 3 study in subjects with T1DM comparing the safety and efficacy of MYL-1601D with NovoLog®. After up to 3-week screening period, all subjects will be titrated on NovoLog® during a 4-week run-in period, and will be shifted from their current basal insulin to study insulin Lantus®. After run-in period, subjects will be randomized; one group will receive MYL-1601D, while the other group will receive NovoLog® for 24 weeks. A follow-up visit, via telephone call, will be scheduled 4 weeks after last dose of MYL-1601D.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	MYL-1601D Product	(100 U/mL)
DRUG	FlexPen NovoLog®	(100 U/mL)

Timeline

• Start date: 2018-11-07
• Primary completion: 2019-12-28
• Completion: 2020-01-17
• First posted: 2018-11-30
• Last updated: 2022-02-25
• Results posted: 2021-01-27

Locations

158 sites across 1 country: United States

Regulatory

• FDA-regulated drug study