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  • 1
    Online Resource
    Online Resource
    Ultra-rapid Lispro (URLi) Reduces Postprandial Glucose Excursions vs. Humalog® in Patients with T2D at Multiple Meal-to-Dose Timing Intervals
    American Diabetes Association ; 2018
    In:  Diabetes Vol. 67, No. Supplement_1 ( 2018-07-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 67, No. Supplement_1 ( 2018-07-01)
    Abstract: URLi (LY900014), a novel ultra-rapid mealtime insulin in Phase 3 development, is shown to reduce postprandial glucose after subcutaneous injection. This 2-part, randomized, double-blind, Phase 1b study evaluated differences in PK and PD between URLi and insulin lispro (Humalog®; HL) in 30 patients with T2D. Part A used a 6-period crossover design to assess safety and compare PK and postprandial glucose response to solid mixed meal tolerance tests (MMTT) with URLi or HL at different injection to mealtime intervals (-15, 0 and +15 min). Part B evaluated safety, PK and PD during 2 weeks of multiple daily dosing (immediately before a meal) in a parallel design.In Part A, URLi reduced glucose excursions (assessed as change in area under the concentration curve vs. time [∆AUC]) during the first 2 hours (∆AUC0-2h) and entire 5 hours (∆AUC0´5h) of the MMTT regardless of dose timing (Fig). URLi reduced ∆AUC0-2h by 37% (p=0.014), 47% (p & lt;0.0001), and 4% (p=NS) and ∆AUC0-5h by 49% (p=0.049), 105% (p & lt;0.0001), and 29% (p=0.076) vs. HL at ´15, 0 and +15 min (significance level =0.1). The PK and PD profiles for URLi and HL were sustained after 2 weeks of outpatient dosing (Part B). More hypoglycemic events occurred with URLi during MMTTs but these were mild and mostly asymptomatic. Only a few events occurred in either group during 2 weeks of outpatient dosing. Local tolerability was similar between treatments. Disclosure C. Kapitza: Research Support; Self; ADOCIA, Boehringer Ingelheim GmbH, Dance Biopharm, Eli Lilly and Company, Johnson & Johnson Services, Inc., MedImmune, MSD K.K., Mylan, Nordic Bioscience, Novo Nordisk Inc., Poxel SA, Roche Diagnostics Corporation, Saniona, Sanofi-Aventis, Senseonics, Zealand Pharma A/S. J. Leohr: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Employee; Spouse/Partner; Accenture. Stock/Shareholder; Spouse/Partner; Accenture. R. Liu: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. S. Reddy: None. M.A. Dellva: Employee; Self; Eli Lilly and Company. M. Matzopoulos: None. M.P. Knadler: Other Relationship; Self; Eli Lilly and Company. M. Loh: Employee; Self; Eli Lilly and Company. T. Hardy: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. C.M. Kazda: Employee; Self; Eli Lilly and Company.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db18-1009-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
    detail.hit.zdb_id: 1501252-9
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  • 2
    Online Resource
    Online Resource
    Ultra-rapid Lispro (URLi) Shows Faster Absorption of Insulin Lispro vs. Humalog® during Insulin Pump (CSII) Use in Patients with T1D
    American Diabetes Association ; 2018
    In:  Diabetes Vol. 67, No. Supplement_1 ( 2018-07-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 67, No. Supplement_1 ( 2018-07-01)
    Abstract: URLi (LY900014), a novel ultra-rapid mealtime insulin in Phase 3 development, is shown to reduce postprandial glucose after subcutaneous injection. This study evaluated the pharmacokinetics and pharmacodynamics (PD) of URLi via CSII. In a double-blind, randomized cross-over study, 24 adult patients with T1D received URLi or insulin lispro (Humalog®; HL) for 3 days. Mixed meal tolerance tests (MMTT) were conducted on Days 1 and 3 after catheter insertion using a standard (1.5 U/min) single-wave bolus. URLi showed faster insulin lispro absorption on both days compared to HL. URLi reduced time to early half-maximal drug concentration by 37% (-8.5 min) and 32% (-5.3 min) compared to HL on Days 1 and 3 (both p & lt;0.0001). Area under the insulin lispro concentration time curve (AUC) for the first 15 min was & gt;50% higher than HL after dosing with URLi on Days 1 and 3 (p & lt;0.005). URLi reduced 1-hour postprandial glucose excursion of the MMTT by 45% on Day 1 (p=NS) and 47% on Day 3 (p=0.059) compared with HL (Figure). Accelerated URLi absorption was associated with trends toward lower postprandial glucose excursion for the entire MMTT (57% and 20% reductions in ∆AUC[0-5h] on Days 1 and 3; both NS). The study was not powered for PD assessment which may contribute to the lack of statistical significance. No differences were seen in the number or severity of hypoglycemic events or local tolerability between URLi and HL. Disclosure C.M. Kazda: Employee; Self; Eli Lilly and Company. J. Leohr: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Employee; Spouse/Partner; Accenture. Stock/Shareholder; Spouse/Partner; Accenture. R. Liu: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. T. Hardy: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. S. Reddy: None. S.P.C. Chua: Employee; Self; Eli Lilly and Company. X. Guo: None. U. Hovelmann: None. C. Kapitza: Research Support; Self; ADOCIA, Boehringer Ingelheim GmbH, Dance Biopharm, Eli Lilly and Company, Johnson & Johnson Services, Inc., MedImmune, MSD K.K., Mylan, Nordic Bioscience, Novo Nordisk Inc., Poxel SA, Roche Diagnostics Corporation, Saniona, Sanofi-Aventis, Senseonics, Zealand Pharma A/S.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db18-1006-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
    detail.hit.zdb_id: 1501252-9
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  • 3
    Online Resource
    Online Resource
    1112-P: Ultra Rapid Lispro (URLi) Lowers Postprandial Glucose (PPG) and More Closely Matches Normal Physiological Glucose Response Compared with Other Rapid Insulin Analogs
    American Diabetes Association ; 2019
    In:  Diabetes Vol. 68, No. Supplement_1 ( 2019-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion. This randomized, double-blind, 4-period, crossover study, compared the PK and glucodynamics (GD) of URLi, Humalog® (HL), NovoRapid® (NR) and Fiasp® (FA) after a test meal in 68 adults with T1D, after single individualized SC dose. Twelve healthy subjects provided the “normal” insulin secretory and glucose response to the test meal. URLi had the fastest insulin absorption: early half maximal drug concentration was reached at 13 min (URLi), 19 min (FA), 25 min (HL), and 27 min (NR) (p & lt;0.05, URLi vs. other insulins). Early insulin exposure increased more with URLi: 1.5-fold vs. FA, 5-fold vs. HL, and 5-fold vs. NR in the first 15 min after dose (all p & lt;0.002). Late insulin exposure (2h to 7h) was reduced more with URLi: 37% vs. FA, 30% vs. HL, and 45% vs. NR (all p & lt;0.001). URLi significantly reduced PPG excursions up to 4h vs. HL and NR (Figure) and URLi’s PPG profile more closely matched that of healthy subjects in the first 2 hours post-meal (Figure). Hypoglycemic events were similar between insulins during the test meal. URLi demonstrated the fastest insulin absorption and the lowest PPG compared to all insulins tested and more closely matched the normal physiological profile of nondiabetic subjects. Disclosure T. Heise: Advisory Panel; Self; Mylan. Research Support; Self; ADOCIA, Boehringer Ingelheim International GmbH, Dance Biopharm Holdings Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Johnson & Johnson, MedImmune, Mylan, Nordic Bioscience, Novo Nordisk A/S, Pfizer Inc., Poxel, Saniona, Sanofi, Wockhardt, Zealand Pharma A/S. Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. H. Linnebjerg: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. D. Cao: Employee; Self; Eli Lilly and Company. D.E. Coutant: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. E.S. LaBell: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company, Johnson & Johnson, Novartis AG. S. Reddy: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. E. Zijlstra: Speaker's Bureau; Self; Novo Nordisk A/S. C. Kapitza: Research Support; Self; ADOCIA, Biocon, Boehringer Ingelheim Pharmaceuticals, Inc., Dance Biopharm Holdings Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, MedImmune, Mylan, Nestlé, Nordic Bioscience, Novo Nordisk A/S, Poxel SA, Sanofi-Aventis, Wockhardt, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. J.M. Bue-Valleskey: Employee; Self; Eli Lilly and Company. Q. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. J. Leohr: Employee; Spouse/Partner; Accenture. Employee; Self; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Accenture. Stock/Shareholder; Self; Eli Lilly and Company. Funding Eli Lilly and Company
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db19-1112-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
    detail.hit.zdb_id: 1501252-9
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