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 randomized, phase 3 study and liver fat MRI substudy
Diabetes, Obesity and Metabolism Oct 03, 2021
Frías JP, Maaske J, Suchower L, et al. - This extension study revealed better maintained glycemic control, metabolic benefits and efficacy in type 2 diabetes (T2D) patients who received dapagliflozin plus saxagliptin on a background of metformin (DAPA+SAXA+MET) vs those treated with glimepiride plus metformin (GLIM+MET).
A 52-week study showed improvements in glycemic control, liver fat and metabolic variables in T2D patients with background metformin who were treated with dapagliflozin plus saxagliptin (DAPA+SAXA) vs glimepiride (GLIM).
This 104-week extension study continued randomized participants (1:1) on DAPA+SAXA (10/5 mg) plus placebo, or GLIM (1-6 mg) plus placebo, once daily.
For DAPA+SAXA+MET, the requirement for treatment intensification during the 156-week period was lower (37.0%) compared with GLIM+MET (55.6%; hazard ratio 0.52).
Therapeutic glycemic response (glycated hemoglobin <53 mmol/mol; odds ratio 2.1) was achieved, at week 156, by 21.4% of DAPA+SAXA+MET vs 11.7% of GLIM+MET participants.
At week 122, greater adjusted mean decreases from baseline in liver fat and visceral and subcutaneous adipose tissue volumes were achieved with DAPA+SAXA+MET vs GLIM+MET.
The observed safety was consistent with that of the monocomponents.
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