Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperglycemia; Diabetes
Intervention: insulin glargine (Drug); insulin glargine (Drug); insulin glargine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Northwestern University Official(s) and/or principal investigator(s): Mark E Molitch, M.D., Principal Investigator, Affiliation: Northwestern University Feinberg School of Medicine
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.
Clinical Details
Official title: Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Blood Glucose Values Between 80 - 140
Secondary outcome: Percentage of Glucose Values < 50 mg/dLPercentage of Glucose Levels > 180 mg/dL
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Fasting glucose > 100 mg/dl
- Patients on surgical services or in intensive care units receiving intravenous
insulin
Exclusion Criteria:
- Inability to obtain informed consent from patient or next-of-kin
- Allergy to insulin
- Participation in another research study
- Patients for whom there are "do-not-resuscitate" orders
Locations and Contacts
Northwestern Memorial Hospital, Chicago, Illinois 60611, United States
Additional Information
Starting date: July 2004
Last updated: April 3, 2009
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