139-OR: An Obesity-centric Approach With and Without Antiobesity Medications Compared with the Usual-Care Approach to Management of Patients with Obesity and Type 2 Diabetes in an Employer Setting—A Pragmatic Randomized Controlled Trial (EMPOWER-T2D)

Abstract

Objective: Among patients with T2D and obesity, determine the effect of combining anti-obesity medications (AOM) with a comprehensive employer-based weight management program [obesity-centric approach (OCA) + AOM] compared with OCA alone, or usual care (UC) on weight and HbA1c. Methods: A 1-year open-label, randomized, pragmatic clinical trial was conducted at the Cleveland Clinic (CC). Participants were adults with T2D (HbA1c >7.5%) and BMI ≥ 30 kg/m2 enrolled in the CC Employee Health Plan. Participants were randomized 1:1:1 to OCA+ AOM, OCA alone, or UC. Participants in the OCA+AOM group initiated treatment with 1 of 5 US FDA-approved AOMs according to standard practice. Linear mixed effect models were conducted for analysis. Results: A total of 74 participants were randomized (24 OCA+AOM, 26 OCA, and 24 UC). Participants were predominantly female (59%), median age 53.5 (47, 60) years, 68% Caucasian, with baseline median BMI and HbA1c of 37.4 (34.2, 42.7) and 8.8% (7.9, 10.4), respectively. At 1 year, patients that received UC, OCA alone, and OCA + AOM had their mean % weight change (90% confidence interval, CI) by -4.48% (-6.52 to -2.45), -6.68% (-8.71 to -4.65), and -8.74% (-10.64 to -6.74) and mean HbA1c change (90% CI) by -1.65% (-2.09 to -1.22), -2.22% (-2.65 to -1.79), and -2.18% (-2.61 to -1.74), respectively. Only OCA + AOM treatment was found to be non-inferior (P=0.004) to UC approach in weight loss change. OCA + AOM treatment was also found to be superior to UC approach in weight loss change (P=0.022). OCA+AOM and OCA alone were non-inferior to usual-care in HbA1c change (P <0.05), but neither was superior (P>0.05). Conclusion: An OCA +AOM approach to T2D treatment was associated with additional weight loss with non-inferior A1C reductions vs. UC. Larger long-term studies evaluating obesity-focused approaches to T2D management are needed. K.M.Pantalone: Consultant; AstraZeneca, Bayer Inc., Corcept Therapeutics, Diasome, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi, Research Support; Bayer Inc., Merck & Co., Inc., Novo Nordisk, Twin Health, Speaker's Bureau; AstraZeneca, Corcept Therapeutics, Merck & Co., Inc., Novo Nordisk. B.Rogen: None. J.F.Bena: None. H.Xiao: None. G.Barnard: None. E.Borukh: None. S.Peechakara: None. M.L.Griebeler: None. B.Burguera: Research Support; Novo Nordisk.