INSTRIDE 3 Trial
The FDA’s approval of SEMGLEE as biosimilar to, and
interchangeable with LANTUS, is based on evidence that showed
the products are highly similar and that there are no clinically
meaningful differences between SEMGLEE and LANTUS in terms of
safety, purity and potency (safety and
The evidence also showed that SEMGLEE can be expected to produce
the same clinical result as LANTUS in any given patient and that
the risks in terms of safety or diminished efficacy of switching
between SEMGLEE and LANTUS is not greater than the risk of using
LANTUS without such switching.4
| INSTRIDE 3 TRIAL DESIGN4
| Primary Endpoint: Change in HbA1c from baseline
to week 36.
| Secondary Endpoints: Change from baseline in
fasting plasma glucose (FPG), eight-point
self-monitored blood glucose (SMBG) profile and
insulin dose per unit body weight, and
at week 36, in addition to occurrence of
hypoglycaemic events (30-day rate), nocturnal
hypoglycaemic events, and adverse events (AEs).
| Multicenter, open-label, randomized,
parallel-group, phase 3 study.
| Individuals who successfully completed 52 weeks
of reference insulin glargine treatment in the
INSTRIDE 1 study and provided written informed
consent were eligible, for a total of 127
participants with T1DM randomized: 64 to
MYL-1501D and 63 to reference insulin glargine,
77 males, 50 females, aged 18-65 years, BMI
| The reference insulin glargine sequence group
continued reference insulin glargine for 36
weeks. The treatment-switching sequence group
received SEMGLEE for weeks 0 to 12, reference
insulin glargine for weeks 12 to 24, and SEMGLEE
for weeks 24 to 36; after week 36, all
participants resumed their baseline treatment
and had a safety follow-up visit at week 40.
INSTRIDE 3 shows that switching patients between SEMGLEE and
LANTUS resulted in equivalent efficacy and safety.
Overall incidences of any hypoglycemic event or nocturnal
hypoglycemic event were comparable between the groups who
switched between SEMGLEE and LANTUS and who received only LANTUS
over a 36-week period, with no significant difference observed
between treatment sequences at any visit. Overall,
immunogenicity profiles were comparable between the SEMGLEE
switch group and LANTUS-only treatment sequences.