Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial.
OBJECTIVE
To compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).


METHODS
In a controlled multicenter and open-label trial, we randomly assigned patients with DKA to receive intravenous treatment with regular or glulisine insulin until resolution of DKA. After resolution of ketoacidosis, patients treated with intravenous regular insulin were transitioned to subcutaneous NPH and regular insulin twice daily (n = 34). Patients treated with intravenous glulisine insulin were transitioned to subcutaneous 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 intravenous treatment with regular and glulisine insulin. After transition to subcutaneous insulin, there were no differences in mean daily blood glucose levels, but patients treated with NPH and regular insulin had a higher rate of hypoglycemia (blood glucose <70 mg/dl). Fourteen patients (41%) treated with NPH and regular insulin had 26 episodes of hypoglycemia and 5 patients (15%) in the glargine and glulisine group had 8 episodes of hypoglycemia (P = 0.03).


CONCLUSIONS
Regular and glulisine insulin are equally effective during the acute treatment of DKA. A transition to subcutaneous glargine and glulisine after resolution of DKA resulted in similar glycemic control but in a lower rate of hypoglycemia than with NPH and regular insulin. Thus, a basal bolus regimen with glargine and glulisine is safer and should be preferred over NPH and regular insulin after the resolution of DKA.
Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA. geumpie@emory.edu
Guillermo E
GE
Umpierrez
Sidney
S
Jones
Dawn
D
Smiley
Patrick
P
Mulligan
Trevor
T
Keyler
Angel
A
Temponi
Crispin
C
Semakula
Denise
D
Umpierrez
Limin
L
Peng
Miguel
M
Cerón
Gonzalo
G
Robalino
D000328:Adult; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D016883:Diabetic Ketoacidosis / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007328:Insulin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D007336:Insulin, Isophane / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D011994:Recombinant Proteins; D007336:Insulin, Isophane; C479079:insulin glulisine