895-P: Effects of Dapagliflozin, Metformin, or Exercise on Markers of Cardiometabolic Risk: The PRE-D Trial

2019 
We assessed effects of dapagliflozin, metformin or exercise on markers of cardiometabolic health in individuals with prediabetes. Methods: 120 participants were randomized to 13 weeks to either 1) dapagliflozin (DAP, 10 mg once daily); 2) metformin (MET, 850 mg twice daily); 3) exercise (EXE, interval training 5x30 min/week); or 4) control (CON, no treatment). Intention-to-treat analyses were conducted (baseline-adj.). Results: 44% were men. At baseline, the median (Q1; Q3) age was 62 (54; 68) years, HbA1c 41 (39; 43) mmol/mol (5.9 (5.7; 6.1)%), BMI 30.8 (28.6; 34.3) kg/m2, fat mass 34.5 (28.7; 40.7) kg, waist circumference (WC) 104 (97; 113) cm, blood pressure 131/86 (123/79; 144/91) mmHg, cardiorespiratory fitness (CRF) 23.0 (20.4; 27.7) mLO2/kg/min, total cholesterol 5.1 (4.2, 5.9) mmol/L, HDL 1.3 (1.1; 1.5) mmol/L, VLDL 0.6 (0.4; 0.8) mmol/L and triglycerides 1.3 (0.9; 1.8) mmol/L. EXE led to a small reduction (1.1 kg) in fat mass which was also reflected in the change in BMI and weight (Table 1). Small reductions of 2.4 cm in WC were observed in DAP and EXE. In addition, EXE increased CRF by 2.8 mLO2/kg×min and decreased triglycerides and VLDL by 12-13%. DAP increased HDL by 0.1 mmol/l. Conclusion: DAP and EXE led to minor improvements in body composition and lipids. EXE improved cardiorespiratory fitness; otherwise the risk profile of the participants was largely unaffected by the interventions. Disclosure K. Faerch: Research Support; Self; Ascensia Diabetes Care, AstraZeneca, Unilever. Stock/Shareholder; Self; Novo Nordisk A/S. M.B. Blond: None. H. Amadid: None. L.B. Nielsen: None. M. Tvermosegaard: None. M. Ried-Larsen: Other Relationship; Self; Novo Nordisk A/S. K. Karstoft: Employee; Self; Novo Nordisk A/S. 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. Funding Novo Nordisk Foundation; AstraZeneca
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