Distress due to diabetes symptoms and medication side effects is distinct from psychological disorders and can interfere with A1C control and quality of life (QOL). We analyzed patient-reported outcomes (PRO) during a double-blind, 156-wk randomized clinical trial to evaluate effects of gender and treatment on diabetes distress in T2D patients (A1C, 7.5-10.5%) receiving stable metformin (M) ≥1500 mg/d and assigned to either dual add-on therapy with dapagliflozin (D) 10 mg/d + saxagliptin (S) 5 mg/d (n = 227) or single add-on glimepiride (G) titrated 1-6 mg/d (n = 216). A1C, weight and PRO (353 items) were assessed at baseline and wks 12, 28, 52, 104 and 156, and analyzed using linear mixed-effects models. At wk 52, D+S+M resulted in greater reductions in A1C (-1.4±0.1 vs. -1.0±0.1%) and weight (-3.1±0.3 vs. 1.0±0.3 kg) vs. G+M (p<0.001) that remained lower through wk 156. Men had lower A1C at each visit vs. women (all p<0.05). Distress scores (0-100) due to weight gain for D+S+M vs. G+M (83.0±0.8 vs. 75.4±0.9), weight concern (59.9±1.3 vs. 52.5±1.4) and being overweight (40.6±1.2 vs. 44.8±1.2) all favored D+S+M (p<0.01). Model interactions showed that women vs. men experienced greater distress (p = 0.01) that interfered with work, role and daily activities (p<0.001) on G+M compared to D+S+M. Mental health (p = 0.11) and health perceptions (p = 0.59) did not show treatment differences. QOL ratings for women favored D+S+M (p<0.01). Overall satisfaction (78.4±0.3 vs. 76.7±0.3, p<0.001) favored D+S+M, as did subscales of work/role, effectiveness, side effects, burden, preference, net benefit, and regimen acceptance (all p<0.05). Women showed greater improvements in treatment satisfaction compared to men. While addressing diabetes distress to improve a patient’s well-being is important, ameliorating diabetes distress related to medication side effects such as weight gain may also lead to improved adherence, self-care and glycemic control.
M.A. Testa: Stock/Shareholder; Spouse/Partner; GI Windows. Stock/Shareholder; Self; Phase V Technologies, Inc. D.C. Simonson: Stock/Shareholder; Self; GI Windows. Stock/Shareholder; Spouse/Partner; Phase V Technologies, Inc.