Edema
at Injection Site in Phase 3 Studies - PRONTO-T1D and PRONTO-T2D
In
the PRONTO-T1D study, no patient experienced edema at the injection
site.1
In
the PRONTO-T2D study, 1 patient (0.3%) treated with Lyumjev
experienced moderate edema at the injection site on the initial day
of use, which was considered by the investigator to be related to
study drug. The patient was discontinued from the study approximately
3.5 months after the start of the investigational product. The event
was consider unresolved at the last visit of the trial.1
Phase
3 Studies - PRONTO-T1D and PRONTO-T2D
The
phase 3 efficacy and safety studies were designed to compare
Lyumjev with IL-100 in patients with T1DM (PRONTO-T1D) and
in patients with T2DM (PRONTO-T2D).2,3
The
PRONTO-T1D and PRONTO-T2D studies were randomized, double-blind,
controlled, treat-to-target comparisons of Lyumjev and IL-100, both
in combination with either IGlar or IDeg in adults with T1DM and
T2DM, respectively.4
The
PRONTO-T1D study was a 3-treatment group design study that included
2
treatment groups that were administered Lyumjev and IL-100
immediately (0-2 minutes) prior to each meal in a double-blind
manner, and
a
third open-label treatment group that was administered Lyumjev 20
minutes after the start of a meal.1,2
The
PRONTO-T2D study consisted of 2 treatment groups where Lyumjev and
IL-100 were administered immediately (0-2 minutes) prior to each meal
in a double-blind manner.1,3
References
1.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2.
Klaff LJ, Cao D, Dellva MA, et al. Ultra rapid lispro (URLi)
improves postprandial glucose (PPG) control vs. Humalog (lispro) in
T1D: PRONTO-T1D study [abstract 144-OR]. Diabetes. 2019;68(suppl
1). http://dx.doi.org/10.2337/db19-144-OR
3.
Blevins T, Zhang Q, Frias JP, et al. Ultra rapid lispro (URLi)
improves postprandial glucose (PPG) control vs. Humalog (lispro) in
patients with type 2 diabetes (T2D): PRONTO-T2D [abstract 145-OR].
Diabetes. 2019;68(suppl 1).
http://dx.doi.org/10.2337/db19-145-OR
4.
Results from two phase 3 studies show Lilly's ultra rapid lispro
(URLi) met primary efficacy endpoint in people with type 1 and type 2
diabetes. Press release. Eli Lilly and Company; October 2, 2018.
Accessed June 18, 2020.
http://lilly.mediaroom.com/index.php?s=9042&item=137825
Glossary
IDeg
= insulin degludec
IGlar
= insulin glargine
IL-100
= Humalog® (insulin lispro injection) 100 units/mL
PRONTO-T1D
= a Prospective, Randomized, double-blind cOmparison of LY900014 to
iNsulin lispro with an open-label postprandial LY900014 Treatment
group, in cOmbination with insulin glargine or insulin degludec, in
adults with Type 1 Diabetes
PRONTO-T2D
= a Prospective, Randomized, double-blind cOmparison of LY900014 to
iNsulin lispro, boTh in cOmbination with insulin glargine or insulin
degludec in adults with Type 2 Diabetes
T1DM
= type 1 diabetes mellitus
T2DM
= type 2 diabetes mellitus
URLi
= ultra rapid lispro
▼ This
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.