New research shows that an existing type 2 diabetes drug also significantly decreases the risk of other serious conditions. A study published in the New England Journal of Medicine demonstrated that the drug canagliflozin, in addition to helping to treat 2 diabetes, also seems to significantly lower the risk of cardiovascular disease (CVD) and kidney disease in patients with diabetes, Reuters reported.
Renal-related events specifically were to be measured as part of a post-approval safety exploration of canagliflozin (brand name Invokana and Invokamet, Janssen Pharmaceuticals, a Johnson and Johnson company). The published research combined the new CANVAS-Renal Study, designed to be compared directly with data from the original CANVAS study of 2009 before canagliflozin had achieved FDA approval. The renal outcomes were progression of albuminuria and “the renal composite,” a compilation of measures including a 40% reduction in eGFR sustained for at least two consecutive measures, the need for renal replacement therapy (dialysis or transplantation), or death from renal causes.
Progression of albuminuria occurred less frequently among participants assigned to canagliflozin than among those taking placebo (89.4 vs. 128.7 participants with an event per 1000 patient-years). The composite outcome of sustained 40% reduction in eGFR, the need for renal replacement therapy, or death from renal causes occurred less frequently among participants in the canagliflozin group than among those in the placebo group (5.5 vs. 9.0 participants with the outcome per 1000 patient-years).
With regard to the drug’s safety, in late May 2017, the FDA issued a Drug Safety Communication about the increased risk of leg and foot amputations with canagliflozin.
A new trial will test a drug candidate in people with type 1 diabetes and diabetic kidney disease (DKD). GKT831 is the lead drug candidate of French biopharmaceutical company Genkyotex. Labiotech.eu noted that an earlier trial of GKT831 for DKD had focused on both the liver and the kidney. The new, dedicated kidney trial will take place in Melbourne, Australia, at the Barker Heart and Diabetes Institute.
Elias Papatheodorou, CEO of Genkyotex, explained to Labiotech that “regarding DKD, we feel that we did not dose long enough. Instead of 12 weeks, we will be treating for 48 weeks. We will also test a higher dose, since we saw a very good safety profile.” As part of the study, patients will receive 200 mg of oral GKT831 or placebo twice daily for 48 weeks, the company announced.
