905-P: Safety, Adherence, and Treatment Satisfaction with Dapagliflozin, Metformin, or Exercise in Individuals with Prediabetes: The Pre-D Trial

Introduction: Safety, adherence and treatment satisfaction to interventions with dapagliflozin, metformin or exercise in individuals with prediabetes defined by the HbA1c criterion were studied in the randomized controlled PRE-D trial. Methods: 120 participants were randomized 1:1:1:1 to 13 weeks of either: (1) dapagliflozin (DAP, 10 mg daily); (2) metformin (MET, 1700 mg daily); (3) exercise (EXE, 5x30 min/week); or (4) control (CON, no treatment). Adverse events (AE) were collected during the entire study. Satisfaction with the interventions was assessed at 6 and 13 weeks using questionnaires. Adherence was assessed at 6 and 13 weeks by pill count in DAP and MET and each week by uploaded training data in EXE. Comparisons between groups were performed by ANOVA and chi-square tests. Results: At baseline, the median (Q1;Q3) HbA1c was 41 (39;43) mmol/mol (5.9 (5.7;6.1)%); age 62 (54;68) years, and 44% were men. Drop outs were 2 in DAP, 1 in MET, 3 in EXE and 2 in CON. One serious AE occurred in CON (cancer). 40% of the participants experienced at least one AE during the trial (15 in DAP, 22 in MET, 7 in EXE and 4 in CON (DAP vs. MET: P=0.111; MET vs. EXE: P Conclusion: In individuals with prediabetes, treatment with DAP is safe and did not result in more side-effects than treatment with MET. Adherence to all interventions was high, although the most preferred intervention was the EXE intervention. Disclosure H. Amadid: None. M.B. Blond: None. L. Bruhn: None. K.K. Clemmensen: None. C.T. Vaino: None. F. Persson: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Sanofi. Speaker9s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. M.E. Jorgensen: Research Support; Self; Amgen Inc., AstraZeneca, Danish Diabetes Association, Sanofi-Aventis. Stock/Shareholder; Self; Novo Nordisk A/S. K. Faerch: Research Support; Self; Ascensia Diabetes Care, AstraZeneca, Unilever. Stock/Shareholder; Self; Novo Nordisk A/S.