148-OR: IDegLira Improves Glycemic Control in Japanese Patients with Type 2 Diabetes (T2D) Uncontrolled on Premixed Insulin Therapy
Authors: WATADA HIROTAKA , AGNER BUE F. , DOSHI ANKUR , GRØN RANDI , RANTHE MATTIS F. , BILLINGS LIANA K. 
Published: June 2019

Diabetes management is moving towards choosing therapies that reduce treatment burden, risk of hypoglycemia and weight gain. DUAL VII showed that IDegLira, a fixed-ratio insulin degludec (degludec)/liraglutide combination, had non-inferior A1C lowering, lower hypoglycemia rates, no weight gain and less treatment burden vs. basal-bolus therapy. In contrast, there are no trial data on the efficacy and safety of switching patients (pts) from premixed insulin therapy (with basal and bolus components) to a fixed-ratio combination such as IDegLira. DUAL II Japan (NCT02911948) - a 26 week phase 3a multicenter, randomized, double-blind, treat-to-target trial - compared the efficacy and safety of IDegLira vs. ≤50 U degludec in 210 Japanese pts with uncontrolled T2D (A1C 7.5-11.0%) on 20-50 U basal or premixed insulin therapy + metformin ± an oral antidiabetic drug. Primary analysis confirmed superior change in A1C with IDegLira vs. degludec ≤50, and post hoc analyses found the treatment effect was independent of insulin type at baseline (basal or premixed; interaction test, p=0.5229). This post hoc evaluation describes novel data in a subset of 39 pts who switched from premixed insulin to IDegLira. Mean (standard deviation [SD]) A1C was 8.3% (0.73) at baseline and 6.7% (0.93) at Week 26. Mean (SD) body weight reduced by 1.5 (2.9) kg. Daily insulin dose was 14.1 (3.4) U at baseline and 34.2 (11.5) U at Week 26. Rate of hypoglycemic events (defined as severe or plasma glucose &lt;56 mg/dL) was 2.6 events/patient-year of exposure (52 events in 17 pts). No pts withdrew. This post hoc study is the first to evaluate the switch from premixed insulin to IDegLira, in pts with uncontrolled T2D. IDegLira initiation resulted in improved A1C and weight loss with most pts not experiencing hypoglycemic events. This study offers insight into the effectiveness and safety of switching pts from premixed insulin therapy to IDegLira, and provides a support for further investigation into this transition.

Disclosure
H. Watada: Research Support; Self; Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Kissei Pharmaceutical Co., Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Pfizer Inc., Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited. Speaker's Bureau; Self; Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk A/S, Ono Pharmaceutical Co., Ltd., Sanofi, Takeda Pharmaceutical Company Limited, Terumo Medical Corporation. Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Kowa Pharmaceutical Europe Co. Ltd., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Ono Pharmaceutical Co., Ltd., Sanwa Chemical Industry Co. Ltd., Takeda Pharmaceutical Company Limited. B.F. Agner: Employee; Self; Novo Nordisk A/S. A. Doshi: Advisory Panel; Self; Pfizer Inc. Employee; Self; PrimeCare Medical Group. R. Grøn: Employee; Self; Novo Nordisk A/S. M.F. Ranthe: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. L.K. Billings: Advisory Panel; Self; Novo Nordisk A/S, Sanofi-Aventis. Consultant; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S.

Funding
Novo Nordisk A/S