Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment.

David Z I Cherney Eleuterio Ferrannini Guillermo E Umpierrez Anne L Peters Julio RosenstockAmy K CarrollPablo LapuertaPhillip BanksRajiv Agarwal

Published in: Diabetes, obesity & metabolism (2021)

After 26 weeks, HbA1c reductions with sotagliflozin were not statistically significant versus placebo in adults with T2D and CKD4. The 52-week safety profile was consistent with results of the SCORED outcomes trial (NCT03242018).

Keyphrases

phase iii
placebo controlled
chronic kidney disease
study protocol
clinical trial
phase ii
double blind
open label
early onset
gestational age
randomized controlled trial
type diabetes
metabolic syndrome
drug induced
preterm birth