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Lyumjev ® (insulin lispro - aabc) injection
100 units/mL, 200 units/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Was the postprandial reduction in blood glucose in phase 3 Lyumjev® (insulin lispro-aabc) studies greater than the one of Humalog® (insulin lispro)?
In both phase 3 studies, superior postprandial glucose reduction was demonstrated in patients treated with Lyumjev compared with Humalog.
Phase 3 Studies - PRONTO-T1D and PRONTO-T2D
The phase 3 efficacy and safety studies were designed to compare Lyumjev® (insulin lispro-aabc) 100 units/mL and Humalog® (insulin lispro injection) 100 units/mL, in patients with type 1 diabetes (T1D) (PRONTO-T1D) or with type 2 diabetes (T2D) (PRONTO-T2D).1,2
The PRONTO-T1D and PRONTO-T2D studies were randomized, double-blind, controlled, treat-to-target comparisons of Lyumjev and Humalog, both in combination with either insulin glargine or insulin degludec in adults with T1D or T2D, respectively.3
Treatment Groups
The PRONTO-T1D study was a 3-treatment group design study that included
- 2 treatment groups that were administered Lyumjev and Humalog immediately (0 to 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
The PRONTO-T2D study consisted of 2 treatment groups where Lyumjev and Humalog were administered immediately (0-2 minutes) prior to each meal in a double-blind manner.2
End Point at Week 26
At week 26 endpoint, in both phase 3 studies, glycated hemoglobin (HbA1c) was reduced in Lyumjev and Humalog treated groups in comparison with baseline, and noninferiority between treatment groups was shown in patients with diabetes who were randomized to double-blind treatment.1,2
In the open-label arm of the PRONTO-T1D study, at week 26, HbA1c reduction from baseline showed noninferiority between Lyumjev administered 20 minutes after the start of a meal and Humalog administered immediately (0-2 minutes) prior to meal.1
Postprandial Glucose Excursion in Phase 3 Studies
In both phase 3 studies, the secondary efficacy endpoints included superiority 1-hour and 2-hour postprandial glucose excursions in a mixed-meal tolerance test at week 26 after a prandial administration. Superiority was achieved for Lyumjev compared with Humalog when the insulin was administered at 0-2 min prior to meal (Postprandial Glucose Excursion at 1-, 2-, 3- and 4-hour Timepoints in Phase 3 Studies in Patients for Lyumjev With T1D and T2D).1,2
Parameter |
PRONTO-T1D |
PRONTO-T2D |
|||
Mealtime Treatment |
Postmeal Treatment a |
Mealtime Treatment |
|||
Lyumjev |
Humalog |
Lyumjev |
Lyumjev |
Humalog |
|
PPG excursionb |
|||||
At 1-hr, mg/dL |
46.4 (3.33) |
74.3 (3.34) |
87.5 (3.74) |
63.1 (3.60) |
74.9 (3.60) |
At 2-hr, mg/dL |
72.7 (4.50) |
103.9 (4.51) |
97.2 (5.04) |
80.4 (4.50) |
97.8 (4.50) |
At 3-hr, mg/dL |
84.5 (5.08) |
110.9 (5.10) |
93.9 (5.74) |
77.0 (4.98) |
91.9 (4.98) |
At 4-hr, mg/dL |
69.2 (5.31) |
84.8 (5.32) |
73.2 (5.95) |
51.9 (4.76) |
65.7 (4.76) |
LSM difference vs Humalog |
|||||
At 1-hr, mg/dL (95% CI; p value) |
-27.9 (-35.3 to -20.6; p<.001) |
--- |
13.2 (5.0 to 21.4; p=.002) |
-11.8 (-18.1 to -5.5; p<.001) |
|
At 2-hr, mg/dL (95% CI; p value) |
-31.2 (-41.1 to -21.2; p<.001) |
--- |
-6.7 (-17.6 to 4.3) |
-17.4 (-25.3 to -9.5; p<.001) |
|
At 3-hr, mg/dL (95% CI; p value) |
-26.3 (-37.5 to -15.1; p<.001) |
--- |
-16.9 (-29.4 to -4.4; p=.008) |
-14.9 (-23.6 to -6.2; p<.001) |
|
At 4-hr, mg/dL (95% CI; p value) |
-15.5 (-27.3 to -3.8; p=.009) |
--- |
-11.5 (-24.5 to 1.5) |
-13.8 (-22.1 to -5.4; p=.001) |
|
Abbreviations: Humalog = Humalog® (insulin lispro injection) 100 units/mL; LSM = least squares mean; Lyumjev = Lyumjev® (insulin lispro-aabc) 100 units/mL; PPG = postprandial glucose; 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; T1D = type 1 diabetes; T2D = type 2 diabetes.
aTreatment given 20 min after the meal.
bLSM (SE).
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Klaff L, Cao D, Dellva MA, et al. Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: results from the 26-week PRONTO-T1D study. Diabetes Obes Metab. 2020;22(10):1799-1807. https://doi.org/10.1111/dom.14100
2Blevins T, Zhang Q, Frias JP, et al; PRONTO-T2D Investigators. Randomized double-blind clinical trial comparing ultra rapid lispro with lispro in a basal-bolus regimen in patients with type 2 diabetes: PRONTO-T2D. Diabetes Care. 2020;43(12):2991-2998. https://doi.org/10.2337/dc19-2550
3Results 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 August 27, 2020. http://lilly.mediaroom.com/index.php?s=9042&item=137825
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: January 17, 2023