The landmark study evaluated the efficacy and safety of Invokana versus placebo in patients with chronic kidney disease and type 2 diabetes when used in addition to standard of care.
Study results also showed Invokana reduced the risk of the secondary CV endpoints, including the risk of CV death and hospitalization for heart failure by 31%, major adverse CV events (MACE; composite of nonfatal myocardial infarction [MI], nonfatal stroke and CV death) by 20%, and the risk of hospitalisation for heart failure alone by 39%.
Importantly, the study showed no imbalance in amputation or bone fracture. Additionally, no new safety concerns were identified in this study of high-risk patients.
The data were presented TODAY during a late-breaking clinical trials session at the International Society of Nephrology 2019 World Congress of Nephrology in Melbourne, Australia, and simultaneously published in The New England Journal of Medicine.
The Phase 3 CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation, NCT02065791) clinical trial was a randomized, double-blind, event-driven, placebo-controlled, parallel-group, 2-arm, multicenter study.
It evaluated 4,401 patients with T2D, Stage 2 or 3 CKD (defined as an estimated glomerular filtration rate of ≥30 to 300 to ≤5,000 mg/g), who were receiving standard of care including a maximum tolerated labeled daily dose of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers.
In March 2019, Janssen included the CREDENCE data in the submission of a supplemental New Drug Application to the US FDA for Invokana to reduce the risk of ESKD, the doubling of serum creatinine, and renal or CV death for adults with CKD and T2D.
This followed an Independent Data Monitoring Committee meeting in July 2018, where the committee recommended that the CREDENCE trial stop early because it met the prespecified criteria for efficacy.
If this new indication is approved, Invokana would be the first diabetes medication to treat both T2D and CKD, and could be an important new treatment option for the ms of patients around the world who live with these illnesses.
In the CREDENCE study, Invokana showed a 30% reduction in the risk of the primary composite endpoint comprised of progression to doubling of serum creatinine, ESKD, and renal or CV death (HR: 0.70; 95% CI: 0.59 to 0.82; p
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
Aprecia names new chief commercial officer
Insulet's Omnipod 5 integration with Abbott FreeStyle Libre 2 Plus Sensor secures CE Mark approval
Kyowa Kirin enrols first subject in phase two tivozanib eye drops (KHK4951) clinical trial
Novo Nordisk to boost manufacturing capacity with acquisition of three fill-finish sites
Breye Therapeutics commences phase 1b/2a danegaptide clinical trial
DexCom Inc breaks ground on new manufacturing facility in Ireland
VibroSense Dynamics AB secures provisional patent for chemotherapy-induced nerve damage prediction
Innovent Biologics signs collaboration agreement with Sanegene Bio USA
Japan approves GSK's filing for Arexvy vaccination for at-risk adults
Arecor Therapeutics plc extends collaboration with Eli Lilly
OptiBiotix Health partners with Ravenswood for SlimBiome distribution in Australia and New Zealand
Boehringer Ingelheim granted European approval of oral liquid medication for feline diabetes