Lyumjev ® (insulin lispro)

För fullständig produktresumé för Lyumjev se FASS.

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Lyumjev® ▼ (insulin lispro): Hypoglykemiska händelser i fas 3-studier

I fas 3-studier resulterade administreringen av Lyumjev i liknande frekvenser och förekomster av hypoglykemiska händelser som Humalog.

URLi - Hypoglycemic Events in Phase 3 Studies

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

In both phase 3 studies, no significant differences in rate or incidence of severe hypoglycemia requiring assistance of another person or documented hypoglycemia (BG <3.0 mmol/L [BG <54 mg/dL]) during the period from baseline to week 26, were shown between URLi (LY900014) and IL-100 treatment groups (Table 1).1,2

Table 1. Severe and all Documented Hypoglycemia Events at 0-26 Weeks in Phase 3 Studies for URLi (LY900014) in Patients With T1DM or 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)

Subjects with ≥ 1 serious hypoglycemia eventc

n (%)

25 (5.5)d

25 (5.7)

15 (4.6)e

3 (0.9)f

6 (1.8)

All documented hypoglycemia (BG <3.0 mmol/L [BG <54 mg/dL])

Events/patient/year

12.46 (0.75)

13.48 (0.82)

14.24 (0.82)

7.57 (0.66)

7.43 (0.56)

RR (95% CI)g

0.92 (0.78, 1.09)h

---

1.06 (0.90, 1.25)i

1.02 (0.81, 1.28)j

All documented hypoglycemia (BG <3.0 mmol/L [BG <54 mg/dL]) with or without symptoms

4 h postmeal, events/patient/year

6.65 (0.44)

6.25 (0.46)

7.18 (0.52)

1.77 (0.27)k

0.98 (0.14)k

RR (95% CI)g

1.06 (0.88, 1.29)l

---

1.15 (0.94, 1.40)m

1.81 (1.19, 2.74)n

>4 h postmeal, events/patient/year

2.72 (0.23)

4.35 (0.51)

3.88 (0.39)

0.44 (0.14)k

0.37 (0.06)k

RR (95% CI)g

0.62 (0.47, 0.83)o

---

0.89 (0.66, 1.21)p

1.22 (0.61, 2.42)q

Nocturnal hypoglycemia

Events/patient/year

1.25 (0.12)

1.75 (0.36)

1.24 (0.15)

0.68 (0.11)

0.53 (0.09)

RR (95% CI)g

0.71 (0.46, 1.12)r

---

0.71 (0.44, 1.13)s

1.29 (0.82, 2.03)t

Abbreviations: LY900014 = ultra rapid lispro; LSM = least squares mean; 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; RR = relative rate; URLi = ultra rapid lispro.

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

b Treatment given 20 min after the meal.

c Severe hypoglycemia = event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the patient has an altered mental status and cannot assist in his/her own care, may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy.

d p=1.0 vs IL-100.

e p=.517 vs IL-100.

f p=.505 vs IL-100.

g Represents URLi/IL-100.

h p=.363 vs IL-100.

i p=.514 vs IL-100.

j p=.873 vs IL-100.

k Documented symptomatic hypoglycemia.

l p=.530 vs IL-100.

m p=.179 vs IL-100.

n p=.005 vs IL-100.

o p=.001 vs IL-100.

p p=.461 vs IL-100.

q p=.575 vs IL-100.

r p=.139 vs IL-100.

s p=.150 vs IL-100.

t p=.276 vs IL-100.

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.

Glossary

BG = blood glucose

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.

Datum fӧr senaste ӧversyn January 28, 2020


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