Expired Study
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Columbus, Ohio 43210


Purpose:

In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).


Study summary:

High sugar (glucose) is common after surgery, even in patients who do not have diabetes. High glucose contributes to severe hospital complications and even death. Insulin infusions appear to reduce this risk, but are generally only continued for a few days after surgery. In this study, we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir). 90 patients who have undergone recent open heart surgery and are requiring an insulin infusion will be enrolled. They will be randomly assigned to one of three doses of detemir, which consists of 50%, 65%, or 80% of the total daily insulin infusion requirement in the fasting state. Subjects will also receive identical mealtime coverage according to the amount of carbohydrate (glucose) that is ingested. It is expected that the high dose group will achieve superior glycemic control without excessive hypoglycemia.


Criteria:

Inclusion Criteria: - diabetes mellitus - post-cardiothoracic surgery - requiring an insulin infusion of at least 1 unit/hour - Age 18-75 Exclusion Criteria: - Glucocorticoids - TPN or tube feeds - Pregnancy - Surgical procedures in the next 48 hours for whom IV insulin will be expected - Expected length of stay less than 48 hours following cessation of the insulin drip - Patients using subcutaneous insulin pumps - Diabetic ketoacidosis - End-stage renal disease - End-stage liver disease - Coma - Potentially sensitive admissions: prisoners, HIV, suicidality - Unable to give consent in English


Study is Available At:


Original ID:

2007H0210


NCT ID:

NCT00717288


Secondary ID:

60016576


Study Acronym:


Brief Title:

Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir


Official Title:

Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir.


Overall Status:

Active, not recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ohio State University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

90


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Kathleen M Dungan, MD
Principal Investigator
Ohio State University

Study Dates

Start Date:July 2008
Completion Date:June 2010
Completion Type:Anticipated
Primary Completion Date:March 2010
Primary Completion Type:Anticipated
Verification Date:October 2010
Last Changed Date:October 26, 2010
First Received Date:July 15, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Percentage of patients requiring an adjustment of greater than 15% in detemir dose at 24 or 48 hours
Time Frame:48 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time required to reach AM glucose target of 80-130 mg/dl
Time Frame:72 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Reversion to intravenous insulin for failure of glycemic control
Time Frame:72 hours
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Mean glucose at 6, 12, 24,48 hours
Time Frame:48 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients with hypoglycemia (defined as glucose <65 mg/dl
Time Frame:48 hours
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Percentage of patients with AM glucose between 80-130 mg/dl on day 2 and 3
Time Frame:day 2, day 3
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Detemir
Description:Detemir dosed at 50% of calculated basal insulin infusion requirements
Arm Name:1
Other Name:Levemir
Intervention Type:Drug
Name:Detemir
Description:Detemir dosed at 65% of calculated basal insulin infusion requirements
Arm Name:2
Intervention Type:Drug
Name:Detemir
Description:Detemir dosed at 80% of calculated basal insulin infusion requirements
Arm Name:3

Study Arms

Study Arm Type:Active Comparator
Arm Name:3
Description:Detemir dosed at 80% of calculated basal insulin infusion requirement
Study Arm Type:Active Comparator
Arm Name:2
Description:Detemir dosed at 65% of calculated basal insulin infusion requirement
Study Arm Type:Active Comparator
Arm Name:1
Description:Detemir dosed at 50% of calculated basal insulin infusion requirement

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ohio State University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Novo Nordisk

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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