RISK OF KETOACIDOSIS WITH LUSEOGLIFLOZIN IN TYPE 2 DIABETES MELLITUS PATIENTS ON MODERATE DOSE INSULIN THERAPY

A RANDOMISED CONTROL TRIAL

Abstract

INTRODUCTION/BACKGROUND
Sodium-glucose cotransporter-2 (SGLT2) inhibitors, one of which is Luseogliflozin, are associated with a recognized risk of euglycemic diabetic ketoacidosis (DKA) particularly in patients on insulin therapy.

METHODOLOGY
This study aimed to assess the risk of ketoacidosis with Luseogliflozin in patients with type 2 diabetes mellitus (T2D) on moderate doses of insulin. This study involved patients who were attending the Endocrine Clinic, with stable disease and no recent acute events. The participants were randomized to either add-on Luseogliflozin to standard medical therapy or standard medical therapy only. Ketoacidosis was assessed using fasting blood and urine ketone pre- and post-intervention. The study duration was 12 weeks. Independent t-test was performed to assess changes in ketone levels. Pearson’s Correlation was performed to determine the relationship between ketone levels with HbA1c and fasting blood glucose.

RESULTS
A total of 40 patients completed the study, with 20 patients receiving Luseogliflozin and the rest were on standard medical therapy. The mean age and HbA1c for patients were 53.6 ± 7.6 years and 9.1 ± 1.4%, respectively. There was a non-statistically significant increase in fasting blood ketones with the addition of Luseogliflozin compared to standard therapy (0.04 ± 0.12 vs 0.05 ± 0.15 mmol/L; p = 0.735). Similarly, there was a non-statistically significant increase in urine ketones (0.03 ± 0.3 vs 0.03 ± 0.1 mmol/L; p = 1.00). Correlation analysis demonstrated that the increased blood ketone levels were more likely to occur with higher HbA1c (r = 0.324; p = 0.04) and higher fasting blood glucose (r = 0.447; p = 0.004).

CONCLUSION
The addition of Luseogliflozin in T2D patients on moderatedose insulin was not associated with a significant increase in fasting blood and urine ketone levels. However, those with higher HbA1c and FBS seemed to be more vulnerable to elevated blood ketone levels. Thus, this study suggests that Luseogliflozin is safe but should be used with caution in those with higher HbA1c and FBS.