Phase 3
Completed N=478
Mylan Insulin Aspart Study
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03760068 ↗
Enrolled (actual)
478
Serious AEs
7.7%
Results posted
Jan 2021
Primary outcomePrimary: Treatment Emergent Antibody Response (TEAR) — 59; 67 Participants
◆ Published Evidence
Emerging
8citations · ~2 / year
Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog<sup>®</sup>) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study.
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.
Linked Publications
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Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog<sup>®</sup>) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Emergent Antibody Response (TEAR) |
59; 67 | — |
| SECONDARY Change in HbA1c From Baseline |
0.10; 0.04 | — |
| SECONDARY Change in Fasting Plasma Glucose From Baseline |
0.400; 0.599 | — |
| SECONDARY Change in Prandial Insulin Dose From Baseline |
0.0079; -0.0008 | — |
| SECONDARY Change in Basal Insulin Dose From Baseline |
0.0053; 0.0001 | — |
| SECONDARY Change in Total Daily Insulin Dose From Baseline |
0.0178; 0.0024 | — |
| SECONDARY Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline |
0.1180; 0.0999 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03760068) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.