Lyumjev ® (insulin lispro)

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Lyumjev® ▼ (insulin lispro): Minskning av postprandial glukos i fas 3-studies

I båda fas 3-studierna visades överlägsen minskning av glukos efter måltid hos patienter som behandlades med Lyumjev jämfört med Humalog.

PPG Excursions in Phase 3 Studies - PRONTO-T1D and PRONTO-T2D

In both phase 3 studies, the secondary efficacy endpoints included superiority 1-hour and 2-hour PPG excursions in a MMTT at week 26 after a prandial administration.  Superiority was achieved for URLi (LY900014) compared with IL-100 when the insulin was administered at 0-2 min prior to meal (Table 1).1,2

Table 1. Postprandial Glucose Excursion at 1-, 2-, 3- and 4-hour Timepoints in Phase 3 Studies in Patients for URLi (LY900014) With T1DM and T2DM

 Parameter

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)
a

PRONTO-T2D2,3
(Mealtime Treatment)

PRONTO-T2D2,3
(Mealtime Treatment)

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)

At 1-hr, mmol/L

2.57 (0.19)

4.13 (0.19)

4.86 (0.21)

3.50 (0.20)

4.16 (0.20)

At 2-hr, mmol/L

4.04 (0.25)

5.77 (0.25)

5.40 (0.28)

4.47 (0.25)

5.43 (0.25)

At 3-hr, mmol/L

4.69 (0.28)

6.16 (0.28)

5.22 (0.32)

4.28 (0.28)

5.10 (0.28)

At 4-hr, mmol/L

3.84 (0.30)

4.71 (0.30)

4.07 (0.33)

2.88 (0.26)

3.65 (0.26)

ETD for PPG excursionc

At 1-hr, mg/dL (95% CI)

-27.9 (-35.3, -20.6)d

---

13.2 (5.0, 21.4)e

-11.8 (-18.1, -5.5)d

At 2-hr, mg/dL (95% CI)

-31.2 (-41.1, -21.2)d

---

-6.7 (-17.6, 4.3)

-17.4 (-25.3, -9.5) d

At 3-hr, mg/dL (95% CI)

-26.3 (-37.5, -15.1)d

---

-16.9 (-29.4, -4.4)f 

-14.9 (-23.6, -6.2) d

At 4-hr, mg/dL (95% CI)

-15.5 (-27.3, -3.8)g

---

-11.5 (-24.5, 1.5)

-13.8 (-22.1, -5.4)h

At 1-hr, mmol/L (95% CI)

-1.55 (-1.96, -1.14)d

---

0.73 (0.28, 1.19)e

-0.66 (-1.01, -0.30)d

At 2-hr, mmol/L (95% CI)

-1.73 (-2.28, -1.18)d

---

-0.37 (-0.98, 0.24)

-0.96 (-1.41, -0.52)d

At 3-hr, mmol/L (95% CI)

-1.46 (-2.08, -0.84)d

---

-0.94 (-1.63,-0.25)f

-0.83 (-1.31, -0.34)d

At 4-hr, mmol/L (95% CI)

-0.86 (-1.51, -0.21)g

---

-0.64 (-1.36, 0.08)

-0.76 (-1.23, -0.30)h

Abbreviations: ETD = estimated treatment difference; LSM = least squares mean; LY900014 = ultra rapid lispro; 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; URLi = ultra rapid lispro.

a Treatment given 20 min after the meal.

b LSM (SE).

c In comparison with IL-100 treated group.

d p<.001.

e p=.002.

f p=.008.

g p=.009.

h p=.001.

Phase 3 Studies - PRONTO-T1D and PRONTO-T2D

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

At week 26 endpoint, in both PRONTO-T1D and PRONTO-T2D 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.1,2 

In the open-label arm of the PRONTO-T1D study, at week 26, HbA1c reduction from baseline showed noninferiority between URLi (LY900014) administered 20 minutes after the start of a meal and IL-100 administered immediately (0-2 minutes) prior to meal.1

References

1. 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

2. 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

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

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]. Indianapolis, IN: Eli Lilly and Company; October 2, 2018. Accessed February 11, 2020. http://lilly.mediaroom.com/index.php?s=9042&item=137825

Glossary

HbA1c = glycated hemoglobin

IDeg = insulin degludec

IGlar = insulin glargine

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

NIM = noninferiority margin

MMTT = mixed-meal tolerance test

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

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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