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.

IDegLira for the real‐world treatment of type 2 diabetes in Italy. Final results from the REX observational study

“…30 Furthermore, IDegLira has recently emerged as a valid and simple alternative to a complex BB insulin regimen for patients with T2D and poorly controlled diabetes, as documented by very high HbA1c (9%-15%). 31 The extent of HbA1c reductions in both groups of patients was consistent with that obtained in other Italian observational studies 21,22 and similar to that reported in the European retrospective study, 25 but also with the results of the randomized controlled trials of the DUAL programme. [7][8][9][10][11][12] In DUAL-V, patients on basal-only insulin randomized to IDegLira had a greater HbA1c reduction of 0.6% than those randomized to continuing and uptitrating basal insulin.…”

“…Moreover, IDegLira is also economically advantageous up to a dosage of 25 units compared with the BB combination 30 . Furthermore, IDegLira has recently emerged as a valid and simple alternative to a complex BB insulin regimen for patients with T2D and poorly controlled diabetes, as documented by very high HbA1c (9%‐15%) 31 …”

The 2022 American Diabetes Association Meeting

“…HbA1c decreased in both groups from 10.8% to 7.7%, but significantly fewer receiving degludec/liraglutide had an episode of glucose<70 mg/dl (22% vs. 36%) and the former had significant weight loss of 3.7 kg versus weight gain of 8.4 kg, albeit with significantly greater likelihood of nausea (12% vs. 1%). 28 McCrimmon et al 29 compared 814 T2D persons receiving insulin glargine/lixisenatide combination versus 814 propensity score matched T2D persons receiving basal‐bolus treatment, finding somewhat lesser HbA1c decrease from 9.2%, by 0.7% versus 0.8%, and significant weight difference at 0.1 kg weight loss versus 0.7 kg weight gain.…”