Patients with poorly controlled type 1 diabetes (T1D) who are receiving insulin experience significant glycemic improvement with adjunctive dapagliflozin, according to findings from a double-blind, randomized, phase 3 trial published in the Lancet Diabetes & Endocrinology.1
Investigators analyzed patient data from the phase 3 parallel-controlled randomized DEPICT-1 trial (Clinicaltrials.gov Identifier: NCT02268214) to evaluate the efficacy and safety of dapagliflozin when added to insulin therapy in patients with inadequately controlled T1D. For the purposes of this study, inadequately controlled T1D was defined as an hemoglobin A1c (HbA1c) between ≥7.7% and ≤11.0% (≥61.0 mmol/mol and ≤97.0 mmol/mol).
Participants were randomly assigned to receive either 5 mg (n=259) or 10 mg (n=259) oral dapagliflozin once per day or placebo (n=260).
Patients receiving 5 mg and 10 mg dapagliflozin experienced significant reductions in HbA1c at 24 weeks compared with placebo (mean difference from baseline to week 24 for 5 mg dapagliflozin vs placebo was –0.42% [P <.0001] and for 10 mg dapagliflozin vs placebo was –0.45% [P <.0001]).
Common adverse events included urinary tract infections (7% vs 4% vs 13 5%), nasopharyngitis (14% vs 12% vs 15%), and headache (4% vs 6% vs 4%) in the 5 mg-dapagliflozin, 10 mg-dapagliflozin, and placebo groups, respectively. The majority of patients in each arm developed hypoglycemia (79% vs 79% vs 80%, respectively).
Although this study demonstrates the potential efficacy of adjunctive dapagliflozin for glycemic control, the study’s 24-week follow-up period provides little insight into the medication’s long-term therapeutic value in T1D.
In patients with type 1 diabetes and inadequate glycemic control, the use of “dapagliflozin should be regarded as a good candidate for adjunct” insulin therapy.
Dandona P, Mathieu C, Phillip M, et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5(11):864-876.