Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717288
• Other study ID #: 2007H0210
• Secondary ID: 60016576
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2008
• Last updated: August 30, 2011
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: August 2011
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• diabetes mellitus

• post-cardiothoracic surgery

• requiring an insulin infusion of at least 1 unit/hour

• Age 18-75

Exclusion Criteria:

• Glucocorticoids

• total parenteral nutrition (TPN) or tube feeds

• Pregnancy

• Surgical procedures in the next 48 hours for whom intravenous (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, human immunodeficiency virus(HIV), suicidality

• Unable to give consent in English

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Detemir
Detemir dosed at 50% of calculated basal insulin infusion requirements
• Detemir
Detemir dosed at 65% of calculated basal insulin infusion requirements
• Detemir
Detemir dosed at 80% of calculated basal insulin infusion requirements

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3	Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3	day 2, day 3	No
Secondary	Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)	Number of patients with hypoglycemia (defined as glucose <65 mg/dl)	48 hours	Yes
Secondary	Reversion to Intravenous Insulin for Failure of Glycemic Control	Number of participants who went back on intravenous insulin for failure of glycemic control.	72 hours	Yes