Dapagliflozin vs Ertugliflozin

NCT00528372 · Phase 3 · completed

The study was randomized, double-blind, placebo-controlled, and included 1,067 enrolled participants, with 558 receiving short-term treatment; its primary HbA1c endpoint is an accepted disease-defining measure for type 2 diabetes. Results were mixed across the primary dose comparisons: 5 mg and 10 mg morning doses significantly outperformed placebo, while 2.5 mg did not, and the exploratory high-baseline-HbA1c group lacked a comparator.

NCT01986881 · Phase 3 · completed

This trial was randomized, double-blind, and placebo-controlled with over 8,000 participants, giving it strong statistical power, and its primary endpoint was a hard clinical composite (cardiovascular death, non-fatal MI, or non-fatal stroke) rather than a lab surrogate. The trial was designed as a cardiovascular-safety non-inferiority study, and the pre-specified margin was met, with the ertugliflozin-placebo hazard ratio's upper confidence bound (1.114) falling below the 1.3 non-inferiority threshold, demonstrating that ertugliflozin does not increase cardiovascular risk versus placebo in this population.