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

NCT ID: NCT00338104

Last Updated: 2009-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-05-31

Brief 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.

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.

Conditions

Hyperglycemia; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

40% Glargine

Patients will receive a dose of glargine insulin equal to 40% of insulin drip rate.

Group Type: EXPERIMENTAL

insulin glargine

Intervention Type: DRUG

Insulin glargine given at 40% of prior stable drip rate.

60% Glargine

Patients will receive a dose of glargine insulin equal to 60% of insulin drip rate.

Group Type: EXPERIMENTAL

insulin glargine

Intervention Type: DRUG

Insulin glargine given at 60% of prior stable drip rate.

80% Glargine

Patients will receive a dose of glargine insulin equal to 80% of insulin drip rate.

Group Type: EXPERIMENTAL

insulin glargine

Intervention Type: DRUG

Insulin glargine given at 80% of prior stable drip rate.

Interventions

insulin glargine

Insulin glargine given at 40% of prior stable drip rate.

Intervention Type: DRUG

insulin glargine

Insulin glargine given at 60% of prior stable drip rate.

Intervention Type: DRUG

insulin glargine

Insulin glargine given at 80% of prior stable drip rate.

Intervention Type: DRUG

Other Intervention Names

Lantus is brand name for Glargine; Lantus is brand name for Glargine; Lantus is brand name for Glargine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Northwestern University Feinberg School of Medicine

Principal Investigators

Mark E Molitch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

References

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. doi: 10.4158/EP.12.6.641.

Reference Type: RESULT

PMID: 17229660 (View on PubMed)

Other Identifiers

0361-028

Identifier Type: -

Identifier Source: org_study_id