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

June 15, 2006
April 3, 2009
July 2004
May 2005   (final data collection date for primary outcome measure)
Percentage of Blood Glucose Values Between 80 - 140 [ Time Frame: First 24 hours after conversion ] [ Designated as safety issue: No ]
Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL
Complete list of historical versions of study NCT00338104 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percentage of blood glucose values below fifty mg per dL.
  • Percentage of blood glucose values above two hundred mg per dL
Not Provided
Not Provided
 
Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperglycemia
  • Diabetes
  • Drug: insulin glargine
    Insulin glargine given at 40% of prior stable drip rate.
    Other Name: Lantus is brand name for Glargine
  • Drug: insulin glargine
    Insulin glargine given at 60% of prior stable drip rate.
    Other Name: Lantus is brand name for Glargine
  • Drug: insulin glargine
    Insulin glargine given at 80% of prior stable drip rate.
    Other Name: Lantus is brand name for Glargine
  • Experimental: 40% Glargine
    Patients will receive a dose of glargine insulin equal to 40% of insulin drip rate.
    Intervention: Drug: insulin glargine
  • Experimental: 60% Glargine
    Patients will receive a dose of glargine insulin equal to 60% of insulin drip rate.
    Intervention: Drug: insulin glargine
  • Experimental: 80% Glargine
    Patients will receive a dose of glargine insulin equal to 80% of insulin drip rate.
    Intervention: Drug: insulin glargine
Schmeltz LR, DeSantis AJ, Schmidt K, O'Shea-Mahler E, Rhee C, Brandt S, Peterson S, Molitch ME. Conversion of intravenous insulin infusions to subcutaneously administered insulin glargine in patients with hyperglycemia. Endocr Pract. 2006 Nov-Dec;12(6):641-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
May 2005
May 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00338104
0361-028
No
Mark E. Molitch, M.D., Northwestern University Feinberg School of Medicine
Northwestern University
Sanofi
Principal Investigator: Mark E Molitch, M.D. Northwestern University Feinberg School of Medicine
Northwestern University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP