Patient-Reported Outcomes (PROs) for Insulin Degludec/Liraglutide (IDegLira) vs. Insulin Glargine (IGlar U100) as Add-On to Sodium-Glucose Co-Transporter-2 Inhibitor (SGLT2i) ± Oral Antidiabetic Drug (OAD) Therapy in Patients with Type 2 Diabetes (T2D)—DUAL IX Trial

Abstract

In DUAL IX, a 26-week, phase 3b, treat-to-target, open-label trial, patients with uncontrolled T2D on SGLT2i ± OADs (N=420) were randomized 1:1 to once-daily IDegLira or IGlar U100 (100 units [U]/mL) add-on therapy. IDegLira was superior to IGlar U100 for A1C (1.9 vs. 1.7% reduction), body weight (0.0 vs. 2.0 kg gain) and hypoglycemia rate (58% lower with IDegLira). PROs were measured at baseline and week 26 with the 5-domain Treatment Related Impact Measure-Diabetes (TRIM-D) questionnaire, with higher scores indicating better outcomes. After 26 weeks, improvements were significantly greater with IDegLira vs. IGlar U100 in total TRIM-D, Treatment Burden domain and especially Diabetes Management domain (Table), including 4 of the 5 individual items (estimated treatment ratio [95% confidence interval]): help you control your diabetes: 2.17 [1.47; 3.21], p<0.0001; help you avoid hyperglycemia: 1.95 [1.32; 2.87], p=0.0007; help you avoid hypoglycemia: 1.62 [1.12; 2.36], p=0.0105; help you manage your weight: 2.44 [1.69; 3.52], p<0.0001; help you prevent feeling tired/lack of energy: 1.36 [0.95; 1.96], p=0.0945. In conclusion, vs. IGlar U100, IDegLira treatment resulted in better clinical and treatment management outcomes. Disclosure M. Brod: Consultant; Self; Novo Nordisk A/S. L.K. Billings: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S, Dexcom, Inc. R.S. Busch: Speaker's Bureau; Self; AbbVie Inc., AstraZeneca. Research Support; Self; Bayer AG, Intarcia Therapeutics, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Amgen Inc.. Research Support; Self; Sanofi US. Speaker's Bureau; Self; Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc.. Research Support; Self; Amarin Corporation. S. Harris: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Amgen Inc., Lilly/Boehringer Ingelheim, Abbott, Janssen. Consultant; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Lilly/Boehringer Ingelheim, Abbott, Janssen. Research Support; Self; Novo Nordisk A/S, Sanofi, Merck, Abbott, AstraZeneca, Janssen. Other Relationship; Self; CIHR, CDA, The Lawson Foundation. C. Morales Portillo: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Abbott. Research Support; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Theracos, Inc., Lexicon Pharmaceuticals, Inc.. Speaker's Bureau; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Abbott. R. Sahay: Advisory Panel; Self; Boehringer Ingelheim, Sanofi, Eli Lilly and Company, Novo Nordisk A/S. Advisory Panel; Spouse/Partner; Intas Pharmaceuticals Ltd., Pfizer Inc.. Speaker's Bureau; Self; Sanofi, Eli Lilly and Company, Boehringer Ingelheim, Dr. Reddys Laboratories, USV Private Limited, Glenmark. Speaker's Bureau; Spouse/Partner; Boehringer Ingelheim. A. Busk: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. S. Eggert: Employee; Self; Novo Nordisk A/S. N. Halladin: Employee; Self; Novo Nordisk A/S. A. Philis-Tsimikas: Research Support; Self; Dexcom, Inc.. Advisory Panel; Self; Dexcom, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Novo Nordisk A/S, Sanofi, Mylan. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc.. Stock/Shareholder; Spouse/Partner; Esperion Therapeutics, Ionis Pharmaceuticals, Inc.. Advisory Panel; Self; AstraZeneca.