Addition of empagliflozin improves daytime glucose in type 1 diabetes
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Empagliflozin added to automated insulin delivery or predictive low-glucose suspend systems significantly benefited daytime glucose levels for people with type 1 diabetes, with no extra hypoglycemia risk, according to new data.
However, risk for ketosis and ketoacidosis remained.
“Future studies with SGLT2 inhibitors will need modifications to closed-loop control algorithms to enhance safety,” Jose Garcia-Tirado, PhD, assistant professor in the Center for Diabetes Technology at the University of Virginia, and colleagues wrote.
For the 8-week randomized controlled crossover trial, the researchers randomly assigned adults with type 1 diabetes to 5 mg per day empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) or no drug as adjunct to insulin therapy.
Participants also were randomly assigned to sequential orders of an automated insulin delivery system (Control-IQ, Tandem Diabetes Care) for 4 weeks or a predictive low-glucose suspend system (Basal-IQ, Tandem Diabetes Care) for 2 weeks. Percent time in range of 70 mg/dL to 180 mg/dL during daytime while on automated insulin delivery served as the primary outcome measure.
Of the 39 participants enrolled, 35 were randomly assigned and 34 (empagliflozin, n = 18; no drug, n = 16) were analyzed according to the intention-to-treat principle. In all, 32 participants (empagliflozin, n = 16; no drug, n = 16) completed the trial.
In primary endpoint analysis, those on automated insulin delivery who received empagliflozin had a higher daytime time in range compared with those who did not receive the drug (81% vs. 71%; mean estimated difference = 9.9 percentage points; 95% CI, 0.6-19.1; P = .04). Similarly, those on a predictive low-glucose suspend system who received empagliflozin had a higher daytime time in range compared with those who did not receive the drug (80% vs. 63%; mean estimated difference = 16.5 percentage points; 95% CI, 7.3-25.7; P < .001).
The researchers wrote that with a longer duration study, it is feasible to achieve an HbA1c target of less than 6.5% with a combination SGLT2 inhibitor plus automated insulin delivery approach. They did note, however, one episode of diabetic ketoacidosis requiring overnight hospitalization, which they deemed triggered by a nonfunctioning insulin pump insertion site and related to SGLT2 inhibitor therapy use; instances of ketosis among participants without DKA on SGLT2 inhibitor therapy were also reported.
“This event highlights the need for further research to develop smarter closed-loop control algorithms, which would help mitigate the risks for ketosis and ketoacidosis that this class of drugs possesses,” the researchers concluded. “However, given the cardio-renal benefit of this class of agents, as long as the DKA risk is adequately addressed and mitigated in research involving next generation of closed-loop control algorithms, SGLT2 inhibitor adjunctive therapies could be an added benefit for people with type 1 diabetes.”
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