Patient-Reported Outcomes in T2D Patients Inadequately Controlled by Metformin Are More Favorable for Dapagliflozin plus Saxagliptin vs. Insulin Glargine

Patients with T2D inadequately controlled by metformin require additional oral antidiabetes agent(s), injected GLP-1 or basal insulin. Although insulin has greater effect on A1C than a DPP-4 or SGLT2 inhibitor, its higher rates of hypoglycemia, weight gain and regimen burden might decrease satisfaction and quality of life. We analyzed patient-reported outcomes (PRO) from patients with T2D inadequately controlled by metformin ± sulfonylurea during an international, randomized, 24-week, open-label, non-inferiority trial (NCT02551874) of dapagliflozin plus saxagliptin add-on (DAPA + SAXA, n = 324) compared to titrated insulin glargine add-on (INS, n = 319). A1C and PRO questionnaires were obtained at baseline and weeks 12 and 24. Baseline data were: 54.0% male; 80.4% white; 60.7% working ≥3 days/week; age 55.5 ± 9.6 years; A1C 9.0 ± 1.0%; BMI 32.2 ± 5.3 kg/m²; diabetes duration 9.4 ± 6.3 years. Overall Satisfaction, Regimen Acceptance and its eight subscales, Net Benefit and Preference subscale, and Weight Concern all favored DAPA + SAXA at week 24 (Table). Quality of life scales favored DAPA + SAXA at week 12, but were not different at week 24. Compared to INS, DAPA + SAXA had greater treatment satisfaction and acceptance, better short-term quality of life, and less burden and concern about weight gain, hypoglycemia and pain despite comparable A1C.