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Sponsors and Collaborators: |
Northwestern University Sanofi-Aventis |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00338104 |
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.
Condition | Intervention | Phase |
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Hyperglycemia Diabetes |
Drug: glargine insulin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin |
Estimated Enrollment: | 75 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | May 2005 |
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:
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Northwestern Memorial Hospital | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Mark E Molitch, M.D. | Northwestern University Feinberg School of Medicine |
Study ID Numbers: | 0361-028 |
Study First Received: | June 15, 2006 |
Last Updated: | June 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00338104 |
Health Authority: | United States: Institutional Review Board |
insulin glargine intravenous subcutaneous |
hospital diabetes glucose inpatient |
Metabolic Diseases Hyperglycemia Glargine Diabetes Mellitus |
Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |