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- Title
In insulin-treated type 1 diabetes, canagliflozin increased diabetic ketoacidosis.
- Authors
Sfeir, Jad G.; Montori, Victor M.
- Abstract
Question In adults with type 1 diabetes mellitus treated with insulin, does canaglifozin add-on treatment increase the risk for diabetic ketoacidosis (DKA)? Methods Design Randomized placebo-controlled trial. ClinicalTrials.gov NCT02139943. Allocation Unclear allocation concealment.* Blinding Blinded* {study sites and sponsor}†. Follow-up period 18 weeks. Setting Not reported. Patients 351 patients 25 to 65 years of age {mean age 42 y, 56% men}† who had type 1 diabetes for ≥1 year, hemoglobin (Hb) A1c level 7.0% to 9.0% (53 to 75 mmol/mol), body mass index 21 to 35 kg/m², and were receiving a stable insulin regimen (multiple daily injections or continuous subcutaneous infusion) for ≥8 weeks. Exclusion criteria included history of type 2 diabetes mellitus; DKA or severe hypoglycemic event in the past 6 months; myocardial infarction, unstable angina, coronary revascularization, or cerebrovascular accident in the past 12 weeks; history of New York Heart Association class III to IV cardiac disease; uncontrolled hypertension; estimated glomerular filtration rate >70 mL/min/1.73 m²; or treatment with an antihyperglycemic other than insulin in the past 12 weeks. Intervention Canagliflozin, 100 mg (n=117), canagliflozin, 300 mg (n=117), or placebo (n=117) once/d before the first meal. Outcomes Safety outcomes included ketone-related adverse events (i.e., acidosis, blood ketone body increased, blood ketone body present, DKA, diabetic ketoacidotic hyperglycemic coma, ketoacidosis, ketonemia, ketonuria, ketosis, metabolic acidosis, or urine ketone body present) and serious DKA. Patient follow-up 93%† (modified intention-to-treat analysis). Main results Risks for any ketone-related adverse events and for serious DKA events requiring hospitalization were increased with canagliflozin compared with placebo (Table). Conclusion In patients with insulin-treated type 1 diabetes mellitus, canagliflozin increased diabetic ketoacidosis.
- Subjects
COMBINATION drug therapy; DIABETIC acidosis; PEOPLE with diabetes; FISHER exact test; GLYCOSYLATED hemoglobin; HYPOGLYCEMIC agents; INSULIN; TYPE 1 diabetes; PROBABILITY theory; STATISTICAL hypothesis testing; BODY mass index; RANDOMIZED controlled trials; TREATMENT effectiveness; DESCRIPTIVE statistics
- Publication
ACP Journal Club, 2016, Vol 165, Issue 2, p1
- ISSN
1056-8751
- Publication type
Article
- DOI
10.7326/ACPJC-2016-165-2-002