Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00338104
First received: June 15, 2006
Last updated: April 3, 2009
Last verified: March 2009
  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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Percentage of Blood Glucose Values Between 80 - 140 [ Time Frame: First 24 hours after conversion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:

  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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338104

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Sanofi
Investigators
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:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014