Effectiveness and Safety of Early Insulin Glargine U100 and Glargine U300 Administration in the Management of Diabetic Ketoacidosis in Adults With Type 1 Diabetes Mellitus: A Randomized Clinical Trial.

OBJECTIVE

Diabetic ketoacidosis (DKA) predominantly affects individuals with type 1 diabetes mellitus (T1DM). This study evaluated the effectiveness and safety of early use of subcutaneous insulin glargine U100 (iGlar U100) or U300 (iGlar U300) alongside intravenous insulin in managing DKA in adults with T1DM.

METHODS

The study included 90 patients with T1DM diagnosed with DKA randomized into 3 groups. In addition to the standard intravenous regular insulin infusion, the iGlar U100 and the iGlar U300 groups received 0.3 units/kg of subcutaneous iGlar U100 and iGlar U300 respectively while the control group received only the standard intravenous insulin infusion.

RESULTS

The mean time to DKA resolution was significantly shorter in the iGlar U100 group (6.78 ± 2.13 h) and iGlar U300 group (6.33 ± 1.94 h) compared to the control group (11.12 ± 6.15 h; P < .001 for both comparisons). Both the iGlar U100 and iGlar U300 groups required significantly lower total insulin dose compared to the control group. No significant differences were observed between the iGlar U100 and iGlar U300 groups concerning the duration to DKA resolution (P = .693) or the total insulin dose administered (P = .908). The incidence rates of hypoglycemia, hypokalemia, rebound hyperglycemia and rebound DKA were similar across the 3 study groups (P = .871, .657, .718 and 1 respectively).

CONCLUSION

Early combination iGlar U100 or iGlar U300 with intravenous insulin infusion was associated with faster resolution of DKA and reduced total insulin requirements without increasing the risk of hypoglycemia or hypokalemia. Both iGlar U100 and U300 displayed similar safety and efficacy.