Efficacy and Safety of Faster Aspart Compared with Insulin Aspart Both with Insulin Degludec in Adults with T1D
Authors: BUSE JOHN B. , CARLSON ANDERS , KOMATSU MITSUHISA , MOSENZON OFRI , ROSE LUDGER , LIANG BO , HORIO HIROSHI , KADOWAKI TAKASHI 
Published: June 2018

Fast-acting insulin aspart (FA) can improve glycemic control in subjects with T1D. To further assess the effect and safety of FA, a multicenter, treat-to-target, 26-week trial (onset 8) randomized subjects with T1D to double-blind mealtime FA (n=342), or insulin aspart (IAsp; n=342), or open-label post-meal FA (n=341), each with insulin degludec. All available information regardless of treatment discontinuation was used for the evaluation of effect. Non-inferiority for the primary endpoint, change from baseline in A1C, was confirmed for mealtime and post-meal FA vs. IAsp (Figure). Mealtime FA was superior to IAsp for 1-h PPG increment using a standard meal test (ETD: -0.90 [-1.36;-0.45] mmol/L; -16.24 [-24.42;-8.05] mg/dL). Self-measured 1 hour PPG increment favored FA at breakfast (ETD: -0.58 [-0.99;-0.17] mmol/L; -10.43 [-17.85;-3.02] mg/dL) and across all meals (ETD: -0.48 [-0.74;-0.21] mmol/L; -8.58 [-13.35;-3.81] mg/dL). No significant differences were observed in treatment-emergent adverse events or overall rate of severe or confirmed hypoglycemic episodes (PG &lt;3.1 mmol/L [56 mg/dL]), but significantly less hypoglycemia was seen 3 to 4 h after meals with mealtime FA.
In summary, mealtime FA provided superior PPG control to IAsp with a similar overall improvement in A1C and no increased safety risk. These findings were consistent with those previously reported in subjects with T1D.

Disclosure
J.B. Buse: Other Relationship; Self; ADOCIA, AstraZeneca, Dexcom, Inc., Elcelyx Therapeutics, Inc., Eli Lilly and Company, Fractyl Laboratories, Inc., Intarcia Therapeutics, Inc., Lexicon Pharmaceuticals, Inc., Metavention, NovaTarg, Novo Nordisk A/S, Sanofi, VTV Therapeutics. Research Support; Self; Boehringer Ingelheim GmbH, Johnson & Johnson Services, Inc., Theracos, Inc.. Other Relationship; Self; Shenzhen Hightide Biopharmaceutical, Ltd.. Research Support; Self; National Heart, Lung, and Blood Institute, National Center for Advancing Translational Sciences. Other Relationship; Self; National Institute of Diabetes and Digestive and Kidney Diseases, American Diabetes Association. Research Support; Self; Patient-Centered Outcomes Research Institute. Other Relationship; Self; National Institute of Environmental Health Sciences. A. Carlson: Advisory Panel; Self; Sanofi, Insulet Corporation. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Medtronic, Novo Nordisk A/S. M. Komatsu: Research Support; Self; Nippon Boehringer Ingelheim Co. Ltd., Sanofi K.K., Ono Pharmaceutical Co., Ltd., MSD K.K., Takeda Pharmaceutical Co Ltd., Mitsubishi Tanabe Pharma Corporation, Astellas Pharma US, Inc., Sumitomo Dainippon Pharma Co., Ltd., Teijin Pharma Limited, Novo Nordisk A/S, Kissei Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Daiichi Sankyo Company, Limited, Fujifilm Pharma Co Ltd, Eli Lilly Japan K.K., Taisho Pharmaceutical Co., Ltd., Novartis Pharma K.K., Kowa Pharmaceutical Co. Ltd.. Speaker's Bureau; Self; Nippon Boehringer Ingelheim Co. Ltd., Sanofi K.K., Ono Pharmaceutical Co., Ltd., MSD K.K., Takeda Pharmaceutical Co Ltd., Mitsubishi Tanabe Pharma Corporation, Astellas Pharma US, Inc., Sumitomo Dainippon Pharma Co., Ltd., Teijin Pharma Limited, Novo Nordisk A/S, Kissei Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Terumo Medical Corporation, Daiichi Sankyo Company, Limited, Fujifilm Pharma Co Ltd, Eli Lilly Japan K.K., Taisho Pharmaceutical Co., Ltd., Novartis Pharma K.K., Bayer Yakuhin, Ltd., Medtronic Japan Co. Ltd., Maruho Co. Ltd., Kowa Pharmaceutical Co. Ltd. O. Mosenzon: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Merck Sharp & Dohme Corp., Boehringer Ingelheim GmbH, AstraZeneca. Consultant; Self; Novo Nordisk A/S, Merck Sharp & Dohme Corp., AstraZeneca. Research Support; Self; Novo Nordisk A/S, AstraZeneca. Speaker's Bureau; Self; Novo Nordisk A/S, Sanofi, Merck Sharp & Dohme Corp., Boehringer Ingelheim GmbH, AstraZeneca, Eli Lilly and Company, Novartis AG. L. Rose: Advisory Panel; Self; Novo Nordisk A/S. Consultant; Self; Member of Association of Statutory Health Insurance Physicians. B. Liang: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Pfizer ApS, H. Lundbeck A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Pfizer Inc. H. Horio: Employee; Self; Novo Nordisk Pharma Ltd.. Employee; Spouse/Partner; Chugai Clinical Research Center Co., Ltd. T. Kadowaki: Consultant; Self; Novo Nordisk A/S, AstraZeneca, Merck Sharp & Dohme Corp.. Research Support; Self; Kissei Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Sanofi, Kyowa Hakko Kirin Co., Ltd., Novo Nordisk A/S, Astellas Pharma, Daiichi Sankyo Company, Limited, Takeda, Mitsubishi Tanabe Pharma Corporation, Ono Pharmaceutical Co., Ltd., Merck Sharp & Dohme Corp., Nippon Boehringer Ingelheim Co. Ltd.. Speaker's Bureau; Self; Astellas Pharma, AstraZeneca, Merck Sharp & Dohme Corp., Ono Pharmaceutical Co., Ltd., Takeda, Eli Lilly and Company, Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk A/S.