Status:
COMPLETED
Mylan Insulin Aspart Study
Lead Sponsor:
Mylan Inc.
Collaborating Sponsors:
Mylan GmbH
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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, al...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Written and signed informed consent.
- Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.
- Subject is able and willing to comply with the requirements of the study protocol.
- Exclusion Criteria
- History or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk from study participation.
- History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, OR history of significant allergic drug reactions.
- Any clinically significant abnormality in electrocardiogram or safety laboratory tests.
- Any elective surgery requiring hospitalization planned during the study period.
- History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.
- Subjects with major depressive illness in the last 3 years.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Exclusion
Key Trial Info
Start Date :
November 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2020
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT03760068
Start Date
November 7 2018
End Date
January 17 2020
Last Update
February 25 2022
Active Locations (158)
Enter a location and click search to find clinical trials sorted by distance.
1
Endocrinology Associates Montgomery
Montgomery, Alabama, United States, 36106
2
Phoenician Centers for Research
Phoenix, Arizona, United States, 85012
3
Precision Trials
Phoenix, Arizona, United States, 85032
4
Medical Investigations Inc.
Little Rock, Arkansas, United States, 72211