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

Primary Purpose

Hyperglycemia, Diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
insulin glargine
insulin glargine
insulin glargine
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring insulin, glargine, intravenous, subcutaneous, hospital, diabetes, glucose, inpatient

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

40% Glargine

60% Glargine

80% Glargine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Percentage of Blood Glucose Values Between 80 - 140
Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL

Secondary Outcome Measures

Percentage of Glucose Values < 50 mg/dL
Percentage of blood glucose values < 50 mg/dL
Percentage of Glucose Levels > 180 mg/dL
Percentage of blood glucose levels > 180 mg/dL

Full Information

First Posted
June 15, 2006
Last Updated
April 3, 2009
Sponsor
Northwestern University
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00338104
Brief Title
Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
Official Title
Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Northwestern University
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Diabetes
Keywords
insulin, glargine, intravenous, subcutaneous, hospital, diabetes, glucose, inpatient

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
40% Glargine
Arm Type
Experimental
Arm Description
Patients will receive a dose of glargine insulin equal to 40% of insulin drip rate.
Arm Title
60% Glargine
Arm Type
Experimental
Arm Description
Patients will receive a dose of glargine insulin equal to 60% of insulin drip rate.
Arm Title
80% Glargine
Arm Type
Experimental
Arm Description
Patients will receive a dose of glargine insulin equal to 80% of insulin drip rate.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Other Intervention Name(s)
Lantus is brand name for Glargine
Intervention Description
Insulin glargine given at 40% of prior stable drip rate.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Other Intervention Name(s)
Lantus is brand name for Glargine
Intervention Description
Insulin glargine given at 60% of prior stable drip rate.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Other Intervention Name(s)
Lantus is brand name for Glargine
Intervention Description
Insulin glargine given at 80% of prior stable drip rate.
Primary Outcome Measure Information:
Title
Percentage of Blood Glucose Values Between 80 - 140
Description
Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL
Time Frame
First 24 hours after conversion
Secondary Outcome Measure Information:
Title
Percentage of Glucose Values < 50 mg/dL
Description
Percentage of blood glucose values < 50 mg/dL
Time Frame
First 24 hours after conversion
Title
Percentage of Glucose Levels > 180 mg/dL
Description
Percentage of blood glucose levels > 180 mg/dL
Time Frame
First 24 hours after conversion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark E Molitch, M.D.
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17229660
Citation
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.
Results Reference
result

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

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