Additional Relevant Details The approval is based on data from three trials in type 2 diabetes submitted to the European Medicines Agency. In two trials, the combination of saxagliptin and dapagliflozin with metformin resulted in statistically significant reductions in HbA1c in comparison to patients treated with placebo. An additional trial showed that the combination of saxagliptin and dapagliflozin added to metformin resulted in statistically superior reductions in HbA1c in comparison to patients treated with saxagliptin or dapagliflozin alone added to metformin. In these trials, the safety profile of Qtern was similar to the known safety profiles of saxagliptin and dapagliflozin.