SAN DIEGO — Bexagliflozin was effective and well-tolerated in lowering hemoglobin A1c in patients with diabetes and stage 3a/3b CKD, according to study results presented at ASN Kidney Week.
“We run into this problem as chronic kidney disease advances. We have fewer and fewer oral agents to use, despite the fact that diabetes is obviously a leading cause of chronic kidney disease,” Andrew S. Allegretti, MD, of Massachusetts General Hospital, said at a press briefing, here. “Bexagliflozin is an SGLT-2 inhibitor in clinical development, and it has shown excellent results in reducing hemoglobin A1c, serum glucose and in some of the data presented here a few years ago, improving cardiovascular and renal events. The downside right now is that there is no approved SGLT in stage 3b CKD with eGFR below 45.”
In the phase 3, double-blind, placebo-controlled, multicenter, multinational, randomized trial, Allegretti and colleagues assessed 312 patients across 54 study sites with type 2 diabetes and stage 3a/3b CKD. The researchers randomized participants to treatment either with bexagliflozin or placebo for 24 weeks. The study’s primary endpoint was placebo-adjusted change in hemoglobin A1c. The following were designated as secondary endpoints: changes in body weight, systolic BP, albuminuria, fasting plasma glucose and hemoglobin A1c stratified by CKD 3a/3b status.
The researchers analyzed efficacy data using repeated measures methodology with intent-to-treat population to show treatment effects at 24 weeks. They found bexagliflozin lowered hemoglobin A1c by 0.37% compared to placebo. Patients with CKD stage 3a showed reductions in hemoglobin A1c of 0.31%, and those with CKD stage 3b showed reductions in hemoglobin A1c of 0.43%.
Bexagliflozin yielded reductions in body weight, systolic BP, fasting plasma glucose and albuminuria geometric mean ratio. The groups had similar rates of adverse events.
According to Allegretti, the study found bexagliflozin was effective and well-tolerated in patients with diabetes and stage 3a/3b CKD, with similar adverse event rates.
“Additional advantages were reduction in body weight, systolic BP, fasting plasma glucose and albuminuria,” Allegretti said. “The caveat was this was a short study, not specifically powered to analyze long-term kidney and cardiovascular outcomes, but we showed the data over 24 weeks.” – by Jennifer Byrne
Allegretti AS, et al. Paper FR-OR144. Presented at: ASN Kidney Week; Oct. 23-28, 2018. San Diego.
Disclosure: Allegretti reports the study was funded by Theracos LLC.