Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperglycemia Diabetes |
Drug: insulin glargine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin |
- Percentage of Blood Glucose Values Between 80 - 140 [ Time Frame: First 24 hours after conversion ] [ Designated as safety issue: No ]
- Percentage of Glucose Values < 50 mg/dL [ Time Frame: First 24 hours after conversion ] [ Designated as safety issue: Yes ]
- Percentage of Glucose Levels > 180 mg/dL [ Time Frame: First 24 hours after conversion ] [ Designated as safety issue: Yes ]
| Enrollment: | 75 |
| Study Start Date: | July 2004 |
| Study Completion Date: | May 2005 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 40% Glargine
Patients will receive a dose of glargine insulin equal to 40% of insulin drip rate.
|
Drug: insulin glargine
Insulin glargine given at 40% of prior stable drip rate.
Other Name: Lantus is brand name for Glargine
|
|
Experimental: 60% Glargine
Patients will receive a dose of glargine insulin equal to 60% of insulin drip rate.
|
Drug: insulin glargine
Insulin glargine given at 60% of prior stable drip rate.
Other Name: Lantus is brand name for Glargine
|
|
Experimental: 80% Glargine
Patients will receive a dose of glargine insulin equal to 80% of insulin drip rate.
|
Drug: insulin glargine
Insulin glargine given at 80% of prior stable drip rate.
Other Name: Lantus is brand name for Glargine
|
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:
- 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;
- 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;
- 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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Mark E Molitch, M.D. | Northwestern University Feinberg School of Medicine |
More Information
Publications:
| Responsible Party: | Mark E. Molitch, M.D., Northwestern University Feinberg School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00338104 History of Changes |
| Other Study ID Numbers: | 0361-028 |
| Study First Received: | June 15, 2006 |
| Results First Received: | December 1, 2008 |
| Last Updated: | April 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
insulin glargine intravenous subcutaneous |
hospital diabetes glucose inpatient |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glargine |
Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013