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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338104
• Other study ID #: 0361-028
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2006
• Last updated: April 3, 2009
• Start date: July 2004
• Est. completion date: May 2005

Study information

• Verified date: March 2009
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Intervention

Drug:
• insulin glargine
Insulin glargine given at 40% of prior stable drip rate.
• insulin glargine
Insulin glargine given at 60% of prior stable drip rate.
• insulin glargine
Insulin glargine given at 80% of prior stable drip rate.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):64 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Blood Glucose Values Between 80 - 140		First 24 hours after conversion	No
Secondary	Percentage of Glucose Values < 50 mg/dL		First 24 hours after conversion	Yes
Secondary	Percentage of Glucose Levels > 180 mg/dL		First 24 hours after conversion	Yes