6 clinical Trials with diverse drug companies

The clinical research team at the WesternU Center for Clinical and Translational Research completed the Mylan‑sponsored GAZELLE clinical trial in 2019, a Phase 2 randomized, multicenter, open‑label, parallel‑group study designed to compare the safety and efficacy of MYL‑1601D with NovoLog® in patients with Type 1 diabetes mellitus. The study, formally titled “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,” was conducted at the Western University of Health Sciences Patient Care Center between March and December 2019.

As a Phase 2 trial, GAZELLE focused on establishing comparative safety and efficacy metrics between MYL‑1601D—a proposed biosimilar insulin product—and the reference insulin, NovoLog®. The study’s randomized, multicenter, open‑label, parallel‑group design reflects an intent to generate controlled clinical evidence across sites while allowing transparent administration of the investigational and reference products. While the WesternU site completed its portion of the study during the March–December 2019 timeframe, the multicenter nature of GAZELLE suggests coordination with additional clinical sites beyond WesternU to enroll and follow participants according to the protocol. The primary objective reported for the trial was to evaluate and compare safety and efficacy outcomes in individuals diagnosed with Type 1 diabetes mellitus, consistent with Phase 2 goals of assessing therapeutic comparability and informing subsequent larger‑scale studies.

The WesternU completion announcement highlights the operational accomplishment of enrolling and managing a Phase 2 diabetes trial within an academic clinical research environment. The study’s conduction at the Western University Patient Care Center underscores the institution’s capacity to participate in industry‑sponsored clinical investigations, coordinate regulatory and ethical oversight, and deliver multidisciplinary clinical trial management.

Completion of the GAZELLE trial at WesternU represents one of many ongoing clinical research efforts at the institution and contributes data toward the comparative evaluation of MYL‑1601D against an established insulin product. The work aligns academic clinical research capabilities with industry‑sponsored objectives, aiming to expand evidence on potential biosimilar insulin options for people living with Type 1 diabetes.