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
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
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.
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.
Inclusion criteria
Exclusion Criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
San Mateo, California 94401, United States
Overland Park, Kansas 66210, United States
Jefferson City, Missouri 65109, United States
Bend, Oregon 97702, United States