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.

Disclosure

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.

© 2023 by the American Diabetes Association
2023
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.