217-OR: A Randomized Controlled Trial Comparing the Safety and Efficacy of IDegLira vs. Basal Bolus in Patients with Poorly Controlled Type 2 Diabetes and Very High HbA1c (>9%–15%) : IDegLira HIGH Trial

Abstract

IDegLira-HIGH trial was a non-inferiority, prospective, randomized clinical trial, comparing the efficacy and safety of insulin degludec/liraglutide combination (IDegLira) and a regimen of multiple daily injections (MDI) with basal-bolus insulin (BB) in adults (>18-80 years of age) , with type 2 diabetes (T2D) , and very high HbA1c (>9%-15%) , previously treated with basal insulin or multiple oral agents. Primary endpoint was change in HbA1c from baseline to week 26. Secondary endpoints included incidence of hypoglycemia, changes on weight and glycemic variability (% coefficient of variation [%CV]) . Treatment with IDegLira and BB insulin resulted in similar improvement in glycemic control: 7.7±1.7% and 7.7±1.5%, (p=0.76) , with a reduction from baseline of -3.2±2.3% and -3.0±1.8%, (p=0.39) at 26-weeks. IDegLira resulted in lower rates of hypoglycemia <70 mg/dl (22% vs. 36%, p=0.05) , similar glycemic variability (CGM %CV 30.4±9.1% vs. 33.2±7.3%, p=0.08) , and greater weight loss (-3.7±4.1 kg vs. +8.4±5.4 kg, p<0.01) compared to BB. IDegLira was associated with higher rates of nausea (Table 1) . Conclusions: In patients with T2D and very high HbA1c (≥9%-15%) , a regimen of daily IDegLira injection is non-inferior to MDI with BB insulin on HbA1c reduction and was associated with weight loss and less hypoglycemia. Disclosure R.J.Galindo: Advisory Panel; Sanofi, WW International, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk. G.E.Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. B.Moazzami: None. M.F.Scioscia: None. P.Vellanki: n/a. G.M.Davis: Consultant; Medscape, Research Support; Insulet Corporation. F.J.Pasquel: Consultant; AI Health LLC, Boehringer Ingelheim International GmbH, Dexcom, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Merck & Co., Inc. M.Fayfman: None. A.L.Migdal: None. J.Saling: None. Funding Investigator-initiated study to Emory University (PI. Dr. Rodolfo J. Galindo) from Novo Nordisk.