Lyumjev ® (insulin lispro)

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Lyumjev® ▼ (insulin lispro): Fas 3 Pumpeffektivitet och säkerhetsdata

I PRONTO-Pump fas 3-studien visade Lyumjev en trend att förbättra glykemisk kontroll med mindre tid i hypoglykemi och mer tid i blodsockermålområdet, jämfört med IL-100.

URLi - Efficacy and Safety Data in Phase 3 Pump Study

PRONTO-Pump was a phase 3, prospective, randomized, double-blind, crossover, active-controlled, outpatient, multinational study that compared URLi (LY900014) with IL-100, both administered via CSII with Dexcom G5, in adults with T1DM.1

The phase 3 pump study was designed to compare URLi (LY900014) with IL-100 with respect to the rate of infusion set failures in events/patient/30 days that led to

  • premature infusion set changes due to a pump occlusion alarm, or

  • unexplained hyperglycemia with BG >13.9 mmol/L (>250 mg/dL) that did not decrease within 1 hour following a correction bolus delivered via pump.1

Tertiary objectives were investigated to evaluate efficacy and safety outcomes such as

  • change from baseline to week 6 in HbA1c and 1,5-AG levels

  • incremental AUC(0-1) glucose vs time curves after breakfast

  • TIR defined as the duration in minutes of time spent in BG range of 3.9 - 10.0 mmol/L (71-180 mg/dL), and 

  • duration in minutes of time spent in hypoglycemia, defined as BG <2.8 mmol/L (<50 mg/dL).2

Efficacy Results

From baseline to week 6, URLi (LY900014) showed a numerically greater reduction in HbA1c and a larger increase in 1,5-AG compared with IL-100 (Figure 1).1

Figure 1. PRONTO-Pump Study: HbA1c and 1,5-AG Levels in URLi (LY900014) and IL-100 Treatment Groups in Patients With T1DM1,2

Abbreviations: 1,5-AG = 1,5-Anhydroglucitol; HbA1c = glycated hemoglobin; IL-100 = Humalog® (insulin lispro injection) 100 units/mL; PRONTO-Pump = a Prospective, Randomized, double-blind, crossover cOmparison evaluating compatibility and safety of LY900014 and iNsulin lispro with an exTernal cOntinuous subcutaneous insulin infusion system in adult patients with type 1 diabetes; T1DM = type 1 diabetes mellitus; URLi = ultra rapid lispro.

Data presented as mean (SD).

*p<.05.

Continuous Glucose Monitoring

In the study, no significant treatment differences for incremental AUC(0-1) and AUC(0-2) after the start of breakfast was shown. However, a trend toward improved glycemic control was observed in the URLi (LY900014) treatment group compared with the IL-100 treatment group (Figure 2).1

Figure 2. PRONTO-Pump: Glucose Profile Over 0 to 4 Hours in URLi (LY900014) and IL-100 Treatment Groups in Patients With T1DM1,2

Abbreviations: IL-100 = Humalog® (insulin lispro injection) 100 units/mL; PRONTO-Pump = a Prospective, Randomized, double-blind, crossover cOmparison evaluating compatibility and safety of LY900014 and iNsulin lispro with an exTernal cOntinuous subcutaneous insulin infusion system in adult patients with type 1 diabetes; T1DM = type 1 diabetes mellitus; URLi = ultra rapid lispro.

There was no significant treatment difference in the mean duration of time in the BG target range for the daytime, nighttime, and 24-hour periods. However, the mean duration of time in the BG target range was significantly longer in the URLi (LY900014) treatment group compared with the IL-100 treatment group for the time periods of

  • 0 to 1 hour after breakfast (p=.047), and

  • 0 to 2 hours after breakfast (p=.023) (Figure 3).1,2

Figure 3. PRONTO-Pump Study: TIR in the BG Target Range of 3.9 - 10.0 mmol/L (71-180 mg/dL) in URLi (LY900014) and IL-100 Treatment Groups in Patients With T1DM1

Abbreviations: BG = blood glucose; IL-100 = Humalog® (insulin lispro injection) 100 units/mL; LSM = least squares mean; PRONTO-Pump = a Prospective, Randomized, double-blind, crossover cOmparison evaluating compatibility and safety of LY900014 and iNsulin lispro with an exTernal cOntinuous subcutaneous insulin infusion system in adult patients with type 1 diabetes; T1DM = type 1 diabetes mellitus; TIR = time in range; URLi = ultra rapid lispro.

Data presented as LSM difference (95% CI).

*p<.05.

a 6:00 AM to midnight.

b Midnight to 6:00 AM.

Time in Hypoglycemia

In the study, there was no significant treatment difference in the mean duration of time in hypoglycemia defined as BG <2.8 mmol/L (<50 mg/dL) for daytime, nighttime, and 24-hour period. However, there was a trend towards less time in hypoglycemia for the URLi (LY900014) treatment group compared with the IL-100 treatment group (Figure 4).1,2

Figure 4. PRONTO-Pump Study: Time in Hypoglycemia With BG <2.8 mmol/L (<50 mg/dL) in URLi (LY900014) and IL-100 Treatment Groups in Patients With T1DM1

Abbreviations: BG = blood glucose; IL-100 = Humalog® (insulin lispro injection) 100 units/mL; LSM = least squares mean; PRONTO-Pump = a Prospective, Randomized, double-blind, crossover cOmparison evaluating compatibility and safety of LY900014 and iNsulin lispro with an exTernal cOntinuous subcutaneous insulin infusion system in adult patients with type 1 diabetes; T1DM = type 1 diabetes mellitus; URLi = ultra rapid lispro.

Data presented as LSM difference (95% CI).

a 6:00 AM to midnight.

b Midnight to 6:00 AM.

References

1. Bode BW, Liu R, Hardy TA, Ignaut DA. Compatibility and safety of ultra rapid lispro (URLi) with continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes: PRONTO-pump study [abstract 790]. Diabetologia. 2019;62(suppl 1):S383. http://dx.doi.org/10.1007/s00125-019-4946-6

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

Glossary

1,5-AG = 1,5-anhydroglucitol

AUC(0-1) = area under the curve from time 0 to 1 hour

AUC(0-2) = area under the curve from time 0 to 2 hours

BG = blood glucose

CSII = continuous subcutaneous insulin infusion

Dexcom G5 = Dexcom G5® Mobile Continuous Glucose Monitoring System

HbA1c = glycated hemoglobin

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

PRONTO-Pump = a Prospective, Randomized, double-blind, crossover cOmparison evaluating compatibility and safety of LY900014 and iNsulin lispro with an exTernal cOntinuous subcutaneous insulin infusion system in adult patients 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 2019 M10 25


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