(HealthDay News) — For canagliflozin-treated patients with type 2 diabetes, the incidence of serious adverse events of diabetic ketoacidosis (DKA) is low, according to research published in Diabetes Care.
Ngozi Erondu, MPH, from Janssen Research & Development in Raritan, New Jersey, and colleagues examined the incidence of serious adverse events of DKA among canagliflozin-treated patients with type 2 diabetes. Data were included from 17,596 patients from randomized studies of canagliflozin through May 11, 2015.
The researchers identified serious adverse events of DKA and related events in 12 patients (0.07%). These included four (0.07%), six (0.11%) and two (0.03%) patients treated with canagliflozin 100 mg and 300 mg, and comparator, respectively. The corresponding incidence rates per 1,000 patient-years were 0.522, 0.763 and 0.238.
The majority of those with DKA and related events had a blood glucose of greater than 300 mg/dL, received insulin, and had risk factors such as type 1 diabetes/latent autoimmune diabetes of adulthood.
“DKA and related events occurred at a low frequency in the canagliflozin type 2 diabetes program, with an incidence consistent with limited existing observational data in the general population with type 2 diabetes,” the researchers wrote.
The researchers were employed by Janssen Research & Development, which funded the study and developed canagliflozin in collaboration with Mitsubishi Tanabe Pharma Corporation.