Long-term effects of dapagliflozin plus saxagliptin vs glimepiride on a background of metformin in patients with type 2 diabetes: Results of a 104-week extension to a 52-week randomised, phase 3 study and liver fat MRI sub-study
Diabetes, Obesity and Metabolism — Frías JP, Maaske J, Suchower L, et al. | September 15, 2021
In type 2 diabetes (T2D), dapagliflozin+saxagliptin (DAPA+SAXA)+metformin (MET) maintained superior glycemic control, metabolic benefits, and efficacy than glimepiride (GLIM)+MET.
Overall, 382 people took part in the trial, with 338 finishing the 104-week extension period (MRI sub-study, n = 82).
During the 156-week period, DAPA+SAXA+MET (37.0%) required less treatment intensification than GLIM+MET (55.6%).
At week 156, 21.4% of DAPA+SAXA+MET participants compared with 11.7% of GLIM+MET individuals achieved therapeutic glycaemic response (HbA1c, < 7.0%; OR, 2.1; 95%CI, 1.23–3.42).
At week 122, DAPA+SAXA+MET had greater adjusted mean reductions from baseline in liver fat and visceral and subcutaneous adipose tissue volumes than GLIM+MET (LS mean difference from GLIM+MET: −4.89%, −0.41 L, −0.44 L, respectively).
The safety was comparable to that of the mono-components.