What Is Lyumjev - Diabetes On The Net

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What is Lyumjev ? Lyumjev is a mealtime insulin designedto be taken at the start of a meal.1Lyumjev provides a glucose response closer to physiological insulin whencompared to commonly prescribed rapid-acting insulins*4Lyumjev is indicated for the treatment of diabetes mellitus in adults only.Lyumjev is not indicated for use in children¹.Humalog (insulin lispro) is a rapid-acting insulin analogue, indicated forthe treatment of adults and children with diabetes mellitus who requireinsulin for the maintenance of normal glucose homeostasis. Humalog isalso indicated for the initial stabilisation of diabetes mellitus.3Prescribing information and adverse event reporting can be found on page 7.*Commonly used rapid-acting insulins are Humalog , Fiasp , and NovoRapid .Fiasp and NovoRapid are registered trademarks of Novo Nordisk. 2021 Eli Lilly and Company. All rights reserved.Lyumjev , Humalog , KwikPen and Lilly are registered trademarks of Eli Lilly and Company.PP-UR-GB-0092 April 2021.1

Introducing JoannaA Person with Diabetes on Multiple Daily Injections (MDI)of Insulin who could benefit from Lyumjev: E xperienced at managing her basal/bolus therapy F rustrated with frequently high postmeal glucose readings ( 10 mmol/L) T rying her best but worries about theimpact of diabetes on her life2

Inject and Eat with LyumjevPeople with diabetes currently administer mealtime insulin at different times before,during and after a meal.22121%minutes%severalbefore mealseveral minutesbefore meal44%44%at start of mealat start of meal10%10during meal%24%after mealduring mealCould your patients have a simplified and improved inject24afterand eat experience?Lyumjev is the same price as Humalog in the equivalentformulation and is available in the same dose forms:Familiar unit-for-unit dosing simplifies the transition from other mealtime insulins to Lyumjev.Available for adults only in:1 100 units/mL KwikPen Lower volume 200 units/mL KwikPen Half-unit dosing 100 units/mL Junior KwikPen 100 units/mL cartridge for use in reusable Lilly pens 100 units/mL vial3

Lyumjev provides a post-meal glucoseresponse closer to physiological insulin whencompared to other commonly prescribedrapid-acting insulins.*PPG Excursions Following MMTTPostprandial Glucose (PPG) Excursions Following a StandardisedTest Meal in Type 1 Diabetes43.3Data are mean SE.Humalog and NovoRapid were consideredAdults with type1 diabetes (Lyumjev and Humalogcommonly prescribedinsulins.Mean Change FromPremeal Glucose (mmol/L)2.8n 68; Healthy subjects: n 12.This study included arms with NovoRapid and FiaspPhase 1, randomised, double-blind, 4-treatment, 4-period, crossover study in adultsLyumjev with type 1 diabetes(n 68). Patients wererandomised to 1Humalog of 4 treatment sequencesof a single subcutaneous dose of Lyumjev,Fiasp or Fiasp adminisHumalog , NovoRapid tered immediatelybefore the standardised testNovoRapid meal. Prior to dosing, fasting blood glucoseHealthy Subjectslevels were stabilised to 7.4 15% mmol/L by IVglucose or insulin glulisine. Adults without diabetes (n 12) were randomised to weight- andage-match the patients with diabetes and weresubmitted to the standardised test meal for thecomparison analysis of glucose excursions. and Fiasp are registered trademarks of Novo Nordisk12345Time Post Meal (hr)Lyumjev Humalog Fiasp NovoRapid Healthy SubjectsLyumjev had a faster absorption and lower late insulin exposure compared to Fiasp,NovoRapid and Humalog42-7 Hours After Injection5005040040Mean Normalised ExposureRemaining (%)Insulin Lispro or Insulin AspartConcentration (pmol/L)1 Hour After Injection300200100030201000. After Injection (h)LyumjevLyumjev 45Time After Injection (h)NovoRapidFiaspHumalogHumalog Fiasp NovoRapid *Commonly used rapid-acting insulins are Humalog , Fiasp , and NovoRapid .4367

Lyumjev Phase 3 PRONTO-T1D andPRONTO-T2D StudiesThe PRONTO studies were randomised, treat-to-target clinical trials with a double-blind,active controlled component that compared Lyumjev to Humalog and an open-label,observational component that looked at the effect of Lyumjev when taken after meals.Lyumjev significantly outperformed Humalog when dosed at the start of a meal, reducing PPGlevels up to 4 hours.5,6Type 2 Diabetes6Type 1 Diabetes565b4b-1.73 mmol/L(95% CI: -2.28, -1.18)3b2b1a-1.55 mmol/L(95% CI: -1.96, -1.14)PPG Excursions (mmol/L)PPG Excursions (mmol/L)654b-0.96 mmol/L(95% CI: -1.41, -0.52)-0.66 mmol/L(95% CI: -1.01, -0.30)bb3a2a1a000123041Time After Meal (h)234Time After Meal (h)Lyumjev (n 451)(n 442)Lyumjev (n 451) HumalogHumalog (n 442)Lyumjev (n 336)Lyumjev(n 336)Humalog(n 337)Humalog(n 337)MMTT Type 2MMTT Type 1Patients fasted for 8 hours, and FBG had to be in range from 3.9-10.0 mmol/L (71-180 mg/dL) prior to starting the standardised meal test.*Statistically different: 30 minutes and 4 hours (p 0.05); 1, 2, and 3 hours (p 0.001).At 1 hour, 95% CI: -1.01, -0.31; 2 hours, 95% CI: -1.41, -0.53; 3 hours, 95% CI: -1.31, -0.34;4 hours, 95% CI: -1.23, -0.30.Patients fasted for 8 hours and FBG had to be in range from 71 to 180 mg/dL (3.9-10.0 mmol/L) prior tostarting the MMTT.*Statistically different: 15 minutes (p 0.05); 30 minutes, 1, 2, and 3 hours (p 0.001); 4 hours (p 0.05).At 1 hour, 95% CI: -35.3, -20.6; 2 hours, 95% CI: -41.1, -21.2; 3 hours, 95% CI: -37.5, -15.1; 4 hours, 95% CI:Data are-27.3,LSM SE.-3.8.Patients fasted for 8 hours and FBG had to be in range from 71 to 180 mg/dL (3.9-10.0 mmol/L) prior toaP 0.05 startingfor comparisonvs Humalog;the MMTT.bLyumjevpostmeal armvswasHumalog.studied (n 278; injected 20 min after the start of meal). Lyumjev postmealP 0.001A forcomparisonvs Humalog mean PPG excursions were higher at 15 min (p 0.04), 30 min (p 0.001), and 1 hr (p 0.002),andlowerat3hr(p 0.008).Lyumjevpostmeal vs Lyumjev mealtime mean PPG excursions wereFBG fasting blood glucosestatistically higher at 15 min (p 0.001), 30 min (p 0.001), 1 hr (p 0.001), and 2 hr (p 0.001).Overall adverse events (AEs) were comparable betweenLyumjev and Humalog5,6MealtimeLyumjevMealtimeHumalogn (%)n (%)264 (58.5)251 (56.8)36 (8.0)40 (9.0)25 (5.5)25 (5.7)Deaths1 (0.2)1 (0.2)Study discontinuation due to AE1 (0.2)Discontinuations from studytreatment due to an adverse eventCombined injection site reactions*AEsType 1 Diabetes5Overall TEAEsSerious AEsSevere hypoglycaemiaMealtimeLyumjevMealtimeHumalogn (%)n (%)203 (60.4)194 (57.6)26 (7.7)25 (7.4)3 (0.9)6 (1.78)Deaths2 (0.6)1 (0.3)1 (0.2)Study discontinuation due to AE3 (0.9)2 (0.6)6 (1.3)5 (1.1)Discontinuations from studytreatment due to an adverse event6 (1.8)3 (0.9)13 (2.9)1 (0.2)Combined injection site reactions*9 (2.7)0 (0.0)n 451n 442AEsType 2 Diabetes6Overall TEAEsSerious AEsSevere hypoglycaemian 336n 337* For Type 1 Diabetes most common reported were “injection site reaction” and “injection site pain” and for Type 2 Diabetes most common reported was “injection sitepain”AE adverse event; TEAE treatment-emergent adverse event.5

Time in RangeIn the PRONTO-T1D CGM substudy, Lyumjev provided 44 moreminutes* in range during daytime hours (6am to midnight) thanHumalog†744CONSENSUSGlobal consensus gives targets for postprandial glucose andTime in Range to guide glycaemic management strategiesAmerican DiabetesAssociation8Advanced Technologies& Treatments for Diabetes9Postprandial glucose:10 mmol/LTime in range: 70%3.9-10 mmol/LADAAdditionalMinutes(6 am to midnight)ATTDFor more information on Time in Range visitwww.lillydiabetes.co.uk/hcp/lyumjevSummary Simplified Inject and Eat experience for people with diabetes on mealtime insulin Provides a glucose response after meals that is closer to physiological insulin when comparedto commonly prescribed rapid-acting insulins‡4 With Lyumjev, there was no increased risk of hypoglycaemia compared to Humalog5,6For more information on Lyumjev and to access useful patient resources,visit our website: www.lillydiabetes.co.uk* p 0.02.† N 269 adults with Type 1 diabetes. Humalog: daytime, 560 minutes/52% TIR; Lyumjev: daytime, 603 minutes/56% TIR.‡ Commonly used rapid-acting insulins are Humalog , Fiasp , and NovoRapid .References:1. Lyumjev Summary of Product Characteristics2. Datye K et al. J Diabetes Sci Technol. 2018;12: 349-3553. Humalog Summary of Product Characteristics4. Heise T et al. Diabetes Obes Metab. 2020; 22: 1789-17985. Klaff L et al. Diabetes Obes Metab. 2020;22:1799-180766. Blevins T et al. Diabetes Care. 2020; 43:2991-29987. Malecki MT et al. Diabetes Technol Ther 2020; 22: 853-8608. American Diabetes Association. Standards of medical care in diabetes - 2021.Diabetes Care. 2021; 44 (suppl 1): S1-S2329. Battelino T et al. Diabetes Care 2019; 42: 1593-1603

Prescribing InformationPlease click here for Lyumjev prescribing informationPlease click here for Humalog prescribing informationAdverse events and product complaints shouldbe reported. Reporting forms and informationcan be found at: www.mhra.gov.uk/yellowcardor search for MHRA Yellow Card in the GooglePlay or Apple App Store.Adverse events and product complaints shouldalso be reported to Lilly: please call Lilly UK on01256 315 000.7

Inject and Eat with Lyumjev People with diabetes currently administer mealtime insulin at different times before, during and after a meal.2 44% at start of meal 21% several minutes before meal 10% during meal 24% 44% after meal at start of meal 21% several minutes before meal 10% during meal 24% after meal

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Inject and Eat with Lyumjev People with diabetes currently administer mealtime insulin at different times before, during and after a meal.2 44% at start of meal 21% several minutes before meal 10% during meal 24% 44% after meal at start of meal 21% several minutes before meal 10% during meal 24% after meal

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