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Invokana shows benefits in treatment of type 1 diabetes
Reduced HbA1c, body weight and insulin dose without increases in hypoglycemia were found among patients assigned Invokana, according to recent study findings published in Diabetes Care.
However, there were increased rates of ketone-related adverse events, including diabetic ketoacidosis (DKA), according to the researchers.
Robert R. Henry, MD, of the VA San Diego Healthcare System and the University of California, San Diego, and colleagues evaluated data from 351 adults with type 1 diabetes to determine the safety and efficacy of Invokana (canagliflozin, Janssen) as an add-on to insulin. Participants were on multiple daily insulin injections or subcutaneous insulin infusion. Participants were randomly assigned 100 mg (n = 117) or 300 mg (n = 117) canagliflozin or placebo (n = 117) and were followed for 18 weeks.
Robert R. Henry
Compared with placebo, participants on both doses of canagliflozin had HbA1c reductions of 0.4% or more at 18 weeks (P < .001 for both comparisons). Reductions in body weight and insulin dose were also found among the canagliflozin groups.
The rates of hypoglycemia were similar across all groups (94.9% for 100 mg; 93.2% for 300 mg; and 88.9% for placebo), and severe hypoglycemia rates were low among all groups (2.6% for 100 mg; 6.8% for 300 mg; 1.7% for placebo).
Overall adverse events were most common in the 300-mg group (67.5%), followed by the 100-mg group (55.6%) and placebo group (54.7%).
No participants in the placebo group experienced a ketone-related adverse event, unlike those in the canagliflozin groups (5.1%, 100 mg; 9.4%, 300 mg). Similarly, no participants in the placebo group experienced DKA, as opposed to those in the canagliflozin groups (4.3%, 100 mg; 6%, 300 mg).
“The insulin-independent mechanism of action of canagliflozin offers a unique benefit profile in patients with type 1 diabetes, which is different from that of standard insulin therapies that are associated with hypoglycemia and weight gain,” the researchers wrote. “An increase in DKA events was seen with canagliflozin that may be related to the presence of a condition characterized by reduced insulin dose or insulin resistance (eg, illness).” – by Amber Cox
Disclosure: Henry reports various financial ties with Alere, Amgen, AstraZeneca, Boehringer Ingelheim, ClinMet, Eisai, Elcelyx Therapeutics, Eli Lilly, Gilead, Hitachi, Intarcia Therapeutics, Isis Pharmaceuticals, Janssen, Merck, Novo Nordisk, Sanofi, ViaCyte and Vivus. Please see the full study for a list of all other authors’ relevant financial disclosures.