Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)
Condition: Diabetic Ketoacidosis
MeSH terms: Ketosis; Acidosis; Diabetic Ketoacidosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a multicenter, randomized controlled trial 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).
    

Detailed description: 
      Diabetic ketoacidosis (DKA) is the most serious emergency in patients with diabetes. With an
      estimated 100,000 admissions per year in the United States, DKA is also the leading cause of
      death in children with type 1 diabetes, and accounts for a significant proportion of
      admissions in adult patients with type 1 and type 2 diabetes. The mainstay in the treatment
      of DKA involves the continuous intravenous (IV) infusion of regular insulin or the frequent
      subcutaneous (SC) injections of regular or rapid-acting insulin analogs. Multiple studies
      have reported successful protocols for insulin administration during the acute management of
      DKA, but they have failed to address the transition phase from IV to SC maintenance insulin
      regimen. The American Diabetes Association (ADA) position statement recommends the use of
      split-mixed insulin combination of regular and intermediate-acting insulin (NPH). This
      regimen, however, are associated with a high rate of hyperglycemia shortly after
      discontinuation of IV insulin and a risk of hypoglycemia during the hospital stay. Recently,
      the long-acting "basal" insulin glargine (Lantus®, Sanofi Aventis Pharmaceuticals) has been
      shown to facilitate glycemic control with lower rate of hypoglycemic events than
      intermediate-acting insulin in subjects with type 1 and type 2 diabetes. This study aims i)
      to determine the effects of giving a dose of glargine insulin shortly after starting an
      intravenous insulin infusion on glycemic control, time to resolve DKA, and rate of
      hypoglycemia in patients with DKA, and ii) to compare the safety and efficacy of basal/bolus
      (glargine/glulisine) insulin versus the standard split-mixed insulin regimen of NPH and
      regular insulin after the resolution of DKA. The hypothesis is that basal (lantus®) insulin
      as compared to NPH insulin shortly after the start of insulin infusion will improve inpatient
      glycemic control in patients with DKA.
    

Intervention name(s): insulin glargine+ glulisine; NPH + Regular insulin
Intervention type(s): Drug; Drug
Intervention description(s): Daily insulin glargine + glulisine before meals; Split-mixed NPH + Regular insulin twice daily
Other intervention name(s): glargine (Lantus) + glulisine (Apidra); Isophane Insulin(NPH); Intermediate acting Insulin (NPH)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic ketoacidosis; insulin therapy; DKA