Albuminuria-lowering effect of dapagliflozin alone and in combination with saxagliptin and effect of dapagliflozin and saxagliptin on glycaemic control in patients with type 2 diabetes and chronic kidney disease (DELIGHT): a randomised, double-blind, placebo-controlled trial

This study is registered with ClinicalTrials.gov, number NCT02547935 and is completed.FindingsThe study took place between July 14, 2015, and May 18, 2018. 1187 patients were screened, of whom 461 were randomly assigned: 145 to the dapagliflozin group, 155 to the dapagliflozin–saxagliptin group, and 148 to the placebo group (13 patients were excluded because of data integrity issues). Dapagliflozin and dapagliflozin–saxagliptin reduced UACR versus placebo throughout the study period. At week 24, the difference (vs placebo; n=134 patients with available data) in mean UACR change from baseline was −21·0% (95% CI −34·1 to −5·2; p=0·011) for dapagliflozin (n=132) and −38·0% (−48·2 to −25·8; p<0·0001) for dapagliflozin–saxagliptin (n=139). HbA1c was reduced in the dapagliflozin–saxagliptin group (n=137) compared with the placebo group (n=118) at week 24 (−0·58% [−0·80 to −0·37; p<0·0001]). The numbers of patients with adverse events (79 [54%] in the dapagliflozin group, 104 [68%] in the dapagliflozin–saxagliptin group, and 81 [55%] in the placebo group) or serious adverse events (12 [8%], 12 [8%], and 16 [11%], respectively) were similar across groups. There were no new drug-related safety signals.InterpretationDapagliflozin with or without saxagliptin, given in addition to angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker treatment, is a potentially attractive option to slow the progression of kidney disease...
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research