Mylan Insulin Aspart Study

• Status: Completed
• Trial end date: 2020-01-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.
• Collaborator: Mylan GmbH
• Treatments: Insulin Aspart

Criteria

Inclusion criteria

1. Written and signed informed consent.

2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.

3. Subject is able and willing to comply with the requirements of the study protocol.

Exclusion Criteria

1. 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.

2. 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.

3. Any clinically significant abnormality in electrocardiogram or safety laboratory tests.

4. Any elective surgery requiring hospitalization planned during the study period.

5. History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.

6. 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