Lyumjev ® (insulin lispro)

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Lyumjev® ▼ (insulin lispro): HbA1c-reduktion i fas 3-studier

I fas 3-studier, vid vecka 26, visades likvärdig HbA1c-minskning hos Lyumjev och Humalog hos patienter med T1DM och T2DM.

SE_cFAQ_URI037_PHASE_3_REDUCTION_IN_A1C
SE_cFAQ_URI037_PHASE_3_REDUCTION_IN_A1C
en-GB

URLi - Change in HbA1c From Baseline to Week 26 in Phase 3 Studies

At week 26 endpoint, in both phase 3 studies, HbA1c was reduced in URLi (LY900014) and IL-100 treated groups in comparison with baseline, and noninferiority between treatment groups was shown in patients with diabetes who were randomized to double-blind treatment (Change in HbA1c From Baseline to Week 26 in Phase 3 Studies for URLi (LY900014) in Patients With T1DM and T2DM).1,2 

Change in HbA1c From Baseline to Week 26 in Phase 3 Studies for URLi (LY900014) in Patients With T1DM and T2DM

Parametera

URLi (LY900014)
(n=451)

IL-100
(n=442)

URLi (LY900014)
(n=329)

URLi (LY900014)
(n=336)

IL-100
(n=337)

 

PRONTO-T1D1,3
(Mealtime Treatment)

PRONTO-T1D1,3
(Mealtime Treatment)

PRONTO-T1D1,3
(Postmeal Treatment)b

PRONTO-T2D2,3
(Mealtime Treatment)

PRONTO-T2D2,3
(Mealtime Treatment)

HbA1c

At baseline, %

7.34 (0.03)

7.33 (0.03)

7.36 (0.04)

7.28 (0.04)

7.31 (0.04)

At baseline, mmol/mol

56.7 (0.34)

56.7 (0.34)

56.9 (0.40)

56.0 (0.42)

56.4 (0.42)

At 26 week, %

7.21 (0.03)

7.29 (0.03)

7.42 (0.04)

6.92 (0.04)

6.86 (0.04)

At 26 week, mmol/mol

55.3 (0.33)

56.1 (0.34)

57.6 (0.39)

52.1 (0.46)

51.5 (0.46)

Change in HbA1c

%

-0.13 (0.03)

-0.05 (0.03)

0.08 (0.04)

-0.38 (0.04)

-0.43 (0.04)

mmol/mol

-1.4 (0.33)

-0.6 (0.34)

0.8 (0.39)

-4.1 (0.46)

-4.7 (0.46)

ETDc

% (95% CI)

-0.08 (-0.16, 0.00)de

---

0.13 (0.04, 0.22)fe

0.06 (-0.05, 0.16)e

mmol/mol (95% CI)

-0.8 (-1.7, 0.0)dg

---

1.4 (0.5, 2.4)fg

0.6 (-0.6, 1.8) g

Abbreviations: ETD = estimated treatment difference; IL-100 = Humalog® (insulin lispro injection) 100 units/mL; LSM = least squares mean; NIM = noninferiority margin; 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; URLi = ultra rapid lispro.

aData presented as geometric LSM (SE) unless otherwise indicated.

bTreatment given 20 min after the meal.

cIn comparison with IL-100 treated group.

dp=.06.

eNIM: (0.4, 0.3) %.

fp=.003.

gNIM: (4.4, 3.3) mmol/mol.

The phase 3 efficacy and safety studies were designed to compare URLi (LY900014) with IL-100 in patients with T1DM (PRONTO-T1D) and in patients with T2DM (PRONTO-T2D).1,2

The PRONTO-T1D and PRONTO-T2D studies were randomized, double-blind, controlled, treat-to-target comparisons of URLi (LY900014) 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 URLi (LY900014) 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 URLi (LY900014) 20 minutes after the start of a meal.1,3

The PRONTO-T2D study consisted of 2 treatment groups where URLi (LY900014) and IL-100 were administered immediately (0-2 minutes) prior to each meal in a double-blind manner.2,3

In the phase 3 studies, the primary objective was to test for noninferiority on HbA1c (NIM=0.4%) of URLi (LY900014) compared with IL-100 in patients with DM. Patients received the treatment between 0 to 2 minutes prior to the meal, in combination with basal IGlar or IDeg for 26 weeks.3

For both phase 3 studies, the primary efficacy endpoint was the change from baseline to week 26 in HbA1c.1,2

References

1Klaff LJ, Cao D, Dellva MA, et al. Ultra rapid lispro (URLi) improves postprandial glucose (PPG) control vs. Humalog (lispro) in T1D: PRONTO-T1D study. Diabetes. 2019;68(suppl 1). American Diabetes Association abstract 144-OR. https://doi.org/10.2337/db19-144-OR

2Blevins 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. Diabetes. 2019;68(suppl 1). American Diabetes Association abstract 145-OR. https://doi.org/10.2337/db19-145-OR

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4Results 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

Glossary

DM = diabetes mellitus

HbA1c = glycated hemoglobin

IDeg = insulin degludec

IGlar = insulin glargine

IL-100 = Humalog® (insulin lispro injection) 100 units/mL

NIM = noninferiority margin

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.

Datum fӧr senaste ӧversyn February 12, 2020


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