Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
Condition: Hyperglycemia; Diabetes
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine the optimal dose of glargine insulin when
      converting from intravenous short-acting continuous insulin infusions in surgical and
      intensive care unit patients using a prospective, controlled, parallel group, randomized
      study design.

      Note: Lantus insulin is the proprietary name for glargine insulin.
    

Detailed description: 
      Critical illness causes an impairment of insulin secretion and insulin action, resulting in
      hyperglycemia even in normal individuals and a worsening of the hyperglycemia in patients
      with diabetes. Normalization of elevated glucose levels by intensive insulin infusion therapy
      in these critically ill patients has been proven to dramatically improve in-hospital
      mortality rates. After glucose levels have been controlled with insulin infusions, the best
      way to convert them to subcutaneous insulin regimens has not been demonstrated conclusively
      but the insulin regimen best suited is a combination of a basal insulin such as glargine
      (Lantus) insulin with premeal insulin boluses using a short-acting insulin such as Lispro or
      Aspart.

      Subjects will be randomized into three groups, 25 subjects in each group, the groups
      differing according to the starting dose of glargine insulin as follows:

        1. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to
           estimate the total daily dose, by 0.4 to get the starting dose of glargine, continuing
           the insulin drip for 5 hours after giving the glargine before stopping the infusion;

        2. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to
           estimate the total daily dose, by 0.6 to get the starting dose of glargine, continuing
           the insulin drip for 5 hours after giving the glargine before stopping the infusion;

        3. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to
           estimate the total daily dose, by 0.8 to get the starting dose of glargine, continuing
           the insulin drip for 5 hours after giving the glargine before stopping the infusion.

      The glargine insulin will then be continued as the basal insulin, adjusting doses every 24
      hours based on the fasting blood glucose level. In addition, patients will receive Lispro or
      Aspart insulin as prandial bolus insulins with the goals premeal being 80 - 120 mg/dl,
      including bedtime. Glucose measurements will be obtained every 1- 4 hours while patients are
      on their insulin infusions, depending upon the stability of their condition and the stability
      of their glucose levels. Following transfer to glargine insulin, they will have glucose
      measured at least four times per day, premeal and bedtime as per standard protocol in the
      hospital for patients receiving insulin. Glucose data will be obtained from such patients and
      this will be compared among the various glargine regimens.
    

Intervention name(s): insulin glargine; insulin glargine; insulin glargine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Insulin glargine given at 40% of prior stable drip rate.; Insulin glargine given at 60% of prior stable drip rate.; Insulin glargine given at 80% of prior stable drip rate.
Other intervention name(s): Lantus is brand name for Glargine; Lantus is brand name for Glargine; Lantus is brand name for Glargine
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insulin; glargine; intravenous; subcutaneous; hospital; diabetes; glucose; inpatient