Insulin Analogs versus Human Insulin in the Treatment of Patients with Diabetic Ketoacidosis: a randomized controlled trial

Abstract

Objective: To compare the safety and efficacy of insulin analogs and human insulins both during the acute intravenous (IV) treatment and during the transition to subcutaneous (SC) insulin in patients with diabetic ketoacidosis (DKA).

Material and Methods: In a controlled multi-center and open label trial we randomized patients with DKA to receive IV treatment with regular or glulisine insulin until resolution of DKA. After resolution of ketoacidosis, patients treated with IV regular insulin were transitioned to SC NPH and regular twice daily (n=34). Patients treated with IV glulisine insulin were transitioned to SC glargine once daily and glulisine before meals (n= 34).

Results: There were no differences in the mean duration of treatment or in the amount of insulin infusion until resolution of DKA between IV treatment with regular and glulisine insulin. After transition to SC insulin, there were no differences in mean daily BG levels, but patients treated with NPH/regular had higher rate of hypoglycemia (BG < 70 mg/dL). Fourteen patients (41%) treated with NPH/regular had 26 episodes of hypoglycemia and 5 patients (15%) in the glargine/glulisine had 8 episodes of hypoglycemia (p=0.03).

Conclusions: Regular and glulisine insulin are equally effective during the acute treatment of DKA. Transition to SC glargine and glulisine following resolution of DKA resulted in similar glycemic control but in a lower rate of hypoglycemia than NPH and regular insulin. Thus, a basal bolus regimen with glargine and glulisine is safer and should be preferred over NPH and regular insulin following the resolution of DKA.