Lyumjev ® (insulin lispro)

För fullständig produktresumé för Lyumjev se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Lyumjev® ▼ (insulin lispro): Kontinuerlig glukosövervakning i fas 3 - HbA1c, PPG och TIR

Jämfört med IL-100 hade Lyumjev signifikant mindre frukost iAUC0-2h, signifikant mer TIR dagtid och liknande natt TIR.

URLi - Continuous Glucose Monitoring Phase 3 Substudy Results in Patients With T1DM

In the phase 3 study in patients with T1DM (PRONTO-T1D), a CGM addendum was included to evaluate 24-hour glucose profiles captured with blinded CGM (Dexcom G4) during treatment with URLi (LY900014) or IL-100, when either was used in combination with basal IGlar or IDeg.1

The primary objective of this substudy was to compare double-blind URLi (LY900014) and IL-100 with respect to the iAUC(0-2h) after breakfast obtained from up to 14 days of CGM use at week 26.1

The secondary objective of this substudy was to compare URLi (LY900014) administered 20 min after the meal (open-label treatment) and IL-100 with respect to the iAUC(0-2h) after breakfast obtained from up to 14 days of CGM use at week 26.1

Glycated Hemoglobin Data

The results showed similar reduction of HbA1c at week 26 for URLi (LY900014) when compared with IL-100 treated group.2 When administered 20 min after the start of the meal, URLi (LY900014) demonstrated a significant increase of HbA1c at week 26 in comparison of IL-100 and URLi (LY900014) administered at the time of breakfast initiation (Table 1).1,2

Table 1. Comparison of HbA1c Data at Week 26 in PRONTO-T1D CGM Substudy1,2

Parametersa

URLi (LY900014)
(n=96 [21%])
b

IL-100
(n=99 [22%])
b

URLi (LY900014)
(n=73 [22%])
b


Mealtime Treatment

Mealtime Treatment

Postmeal Treatmentc

HbA1c at baseline

%

7.24 (0.07)

7.28 (0.07)

7.24 (0.08)

mmol/mol

55.6 (0.73)

56.0 (0.72)

55.7 (0.83)

HbA1c at week 26

%

7.15 (0.06)

7.12 (0.06)

7.35 (0.06)

mmol/mol

54.6 (0.64)

54.4 (0.63)

56.8 (0.70)

ETD at week 26d

% (95% CI)

0.02 (-0.11, 0.16)

---

0.23 (0.08, 0.37)e

mmol/mol (95% CI)

0.3 (-1.2, 1.8)

---

2.5 (0.9, 4.1)e

Abbreviations: CGM = continuous glucose monitoring; ETD = estimated treatment difference; HbA1c = glycated hemoglobin; IL-100 = Humalog® (insulin lispro injection) 100 units/mL; LSM = least squares mean; n = number of subjects in the population with baseline and postbaseline value at week 26; PRONTO-T1D = 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; T1DM = type 1 diabetes mellitus; URLi = ultra rapid lispro.

a Data presented as LSM (SE) unless otherwise indicated.

b Percent of the overall T1DM population.

c Treatment given 20 min after the meal.

d In comparison of IL-100 treated group.

e p=.003 vs IL-100.

Postprandial Glucose Data

URLi (LY900014) demonstrated a significant reduction of the iAUC(0-2h) at week 26 when administered at the time of breakfast initiation compared with IL-100 ( ). When administered at the start of the meal, URLi (LY900014) resulted in a significantly better PPG control compared with IL-100.1,2

Table 2. Comparison of Postprandial Glucose Data at Week 26 in PRONTO-T1D CGM Substudy1,2

Parametersa

URLi (LY900014)
(n=52 [12%])
b

IL-100
(n=53 [12%])
b

URLi (LY900014)
(n=47 [14%])
b


Mealtime Treatment

Mealtime Treatment

Postmeal Treatmentc

iAUC(0-2h) after breakfast

At baseline

mg⋅h/dL

20.1 (10.1)

20.8 (9.9)

43.5 (11.3)

mmol⋅h/L

1.1 (0.6)

1.2 (0.6)

2.4 (0.6)

At week 26

mg⋅h/dL

27.1 (10.8)

55.3 (10.8)

45.2 (11.5)

mmol⋅h/L

1.5 (0.6)

3.1 (0.6)

2.5 (0.6)

ETD at week 26d

mg⋅h/dL (95% CI)

-28.1 (-56.0, -0.3)e

---

-10.1 (-38.7, 18.5)

mmol⋅h/L (95% CI)

-1.6 (-3.1, -0.0)e

---

-0.6 (-2.1, 1.0)

Abbreviations: CGM = continuous glucose monitoring; ETD = Estimated treatment difference; iAUC(0-2h) = incremental area under the curve from time 0 to 2 h; IL-100 = Humalog® (insulin lispro injection) 100 units/mL; LSM = least squares mean; n = number of subjects in the population with baseline and postbaseline value at week 26; PRONTO-T1D = 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; T1DM = type 1 diabetes mellitus; URLi = ultra rapid lispro.

a Data presented as LSM (SE) unless otherwise indicated.

b Percent of the overall T1DM population.

c Treatment given 20 min after the meal.

d In comparison of IL-100 treated group.

e p=.048 vs IL-100.

Time in Glucose Range Data

Compared with IL-100 treated group, URLi (LY900014) showed a significantly greater daytime TIR and similar nighttime TIR (Table 3).2

Table 3. Comparison of Time in Glucose Rangea Data at Week 26 in PRONTO-T1D CGM Substudy1,2

Parametersb

URLi (LY900014)
(n= 85 [19%])
c

IL-100
(n= 81 [18%])
c

URLi (LY900014)
(n= 66 [20%])
c


Mealtime Treatment

Mealtime Treatment

Open-Label Treatmentd

Daytime - TIRe

At week 26, min

603.0 (16.4)f

559.4 (17.4)

554.3 (18.3)

ETD at week 26, min (95% CI)g

43.6 (6.9, 80.3)h

---

-5.1 (-44.1, 33.9)

At week 26, %

55.8 (1.52)

51.8 (1.62)

51.3 (1.69)

ETD at week 26, % (95% CI)g

4.0 (0.6, 7.4)h

---

-0.5 (-4.1, 3.1)

Nighttime - TIRi

At week 26, min

186.7 (7.58)

187.6 (8.21)

181.0 (8.47)

ETD at week 26, min (95% CI)g

-0.9 (-17.9, 16.1)

---

-6.6 (-24.7, 11.5)

At week 26, %

51.9 (2.11)

52.1 (2.28)

50.3 (2.35)

ETD at week 26, % (95% CI)g

-0.2 (-5.0, 4.5)

---

-1.8 (-6.9, 3.2)

Abbreviations: CGM = continuous glucose monitoring; ETD = estimated treatment difference; IL-100 = Humalog® (insulin lispro injection) 100 units/mL; LSM = least squares mean; n = number of subjects in the population with baseline and postbaseline value at week 26; 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; T1DM = type 1 diabetes mellitus; TIR = time in range.

a Glucose target range: 71 to 180 mg/dL or 3.9 to 10.0 mmol/L.

b Data presented as LSM (SE) unless otherwise indicated.

c Percent of the overall T1DM population.

d Treatment given 20 min after the meal.

e Daytime = 06:00 h to midnight.

f N=84.

g In comparison of IL-100 treated group.

h p=.020 vs IL-100.

i Nighttime = midnight to 06:00 h.

References

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

2. Bode BW, Cao D, Liu R, et al. Ultra rapid lispro (URLi) improves postprandial glucose (PPG) control and time in range (TIR) in T1D compared to Humalog® (lispro): PRONTO-T1D continuous glucose monitoring (CGM) sub-study [abstract 1089-P]. Diabetes. 2019;68(suppl 1). http://dx.doi.org/10.2337/db19-1089-P

Glossary

CGM = continuous glucose monitoring

Dexcom G4 = Dexcom G4® Platinum System

HbA1c = glycated hemoglobin

iAUC(0-2h) = incremental area under the curve from time 0 to 2 hours

IDeg = insulin degludec

IGlar = insulin glargine

IL-100 = Humalog® (insulin lispro injection) 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

T1DM = type 1 diabetes mellitus

TIR = time in range

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 October 24, 2019


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Klicka för att chatta är tillgänglig

Klicka för att chatta är offline

Skriv din fråga till oss