147-OR: DUAL VIII: Significantly Longer Time to Treatment Intensification with Insulin Degludec/Liraglutide (IDegLira) vs. Insulin Glargine (IGlar U100) in a 104-Week (Wk) Randomized Trial Mirroring Clinical Practice
Authors: ARODA VANITA R. , GONZALEZ-GALVEZ GUILLERMO , HALUZIK MARTIN , SILVER ROBERT J. , GRØN RANDI , HALLADIN NATALIE , ÖRSY PETRA , SESTI GIORGIO 
Published: June 2019

Patients (pts) (n=1012) with T2D (A1C 7-11%) on oral antidiabetic drugs (OADs) were randomized 1:1 to open label IDegLira or IGlar U100 in a 104 week trial to assess treatment durability. The primary endpoint was time from randomization to treatment intensification (A1C ≥7.0% at 2 consecutive visits including week 26); pts who met the primary endpoint discontinued study drug. Baseline characteristics were similar. Over 104 weeks, fewer pts with IDegLira required intensification vs. IGlar U100 (37.4% vs. 66.2%). Pts treated with IDegLira had a significantly longer time to intensification (median: &gt;2 years/~1 year for IDegLira/IGlar U100; Figure). There was greater effect with IDegLira vs. IGlar U100 after 104 weeks, had intensification not been needed, in terms of: pts achieving A1C &lt;7% (55.7 vs. 28.5%), and A1C &lt;7% with no weight gain (20.9 vs. 6.3%), lower estimated mean insulin dose (36 vs. 51 U; estimated treatment difference -14.9 U), and 56% lower rate of severe or blood glucose confirmed symptomatic hypoglycemia (0.38 vs. 0.86 events/patient-year of exposure, (p&lt;0.0001 for all). Safety results were similar. Improved long-term glycemic control, evidenced by significantly longer time to treatment intensification, was achieved with IDegLira vs. IGlar U100 in pts previously uncontrolled on OADs.

Disclosure

V.R. Aroda: Consultant; Self; ADOCIA, AstraZeneca, Becton, Dickinson and Company, Novo Nordisk Inc., Sanofi, Zafgen, Inc. Employee; Spouse/Partner; Merck & Co., Inc. Research Support; Self; AstraZeneca, Calibra Medical, Eisai Inc., Janssen Research & Development, Novo Nordisk Inc., Sanofi, Theracos, Inc. G. Gonzalez-Galvez: Advisory Panel; Self; Amgen Inc., AstraZeneca, Janssen Pharmaceuticals, Inc., Metabolic Solutions Development Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. Consultant; Self; Amgen Inc., AstraZeneca, Janssen Pharmaceuticals, Inc., Metabolic Solutions Development Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Metabolic Solutions Development Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. M. Haluzik: Advisory Panel; Self; AstraZeneca, Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Consultant; Self; Johnson & Johnson, Lilly Diabetes. Speaker's Bureau; Self; Novartis AG. R.J. Silver: Consultant; Self; Novo Nordisk A/S. Speaker's Bureau; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S. R. Grøn: Employee; Self; Novo Nordisk A/S. N. Halladin: Employee; Self; Novo Nordisk A/S. P. Örsy: Employee; Self; Novo Nordisk A/S. G. Sesti: Advisory Panel; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, GlaxoSmithKline plc., Novo Nordisk A/S, Servier. Consultant; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, GlaxoSmithKline plc., Novo Nordisk A/S, Servier.

Funding

Novo Nordisk A/S