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Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

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ClinicalTrials.gov Identifier: NCT00717288
Recruitment Status : Completed
First Posted : July 17, 2008
Results First Posted : October 3, 2011
Last Update Posted : October 3, 2011
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Kathleen Dungan, Ohio State University

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Detemir Phase 4

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir.
Study Start Date : July 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : June 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
 Drug: Detemir
Detemir dosed at 50% of calculated basal insulin infusion requirements
Other Name: Levemir
Active Comparator: 2
Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
 Drug: Detemir
Detemir dosed at 65% of calculated basal insulin infusion requirements
Active Comparator: 3
Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
 Drug: Detemir
Detemir dosed at 80% of calculated basal insulin infusion requirements


Outcome Measures
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Primary Outcome Measures :
  1. Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 [ Time Frame: day 2, day 3 ]
    Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3


Secondary Outcome Measures :
  1. Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) [ Time Frame: 48 hours ]
    Number of patients with hypoglycemia (defined as glucose <65 mg/dl)

  2. Reversion to Intravenous Insulin for Failure of Glycemic Control [ Time Frame: 72 hours ]
    Number of participants who went back on intravenous insulin for failure of glycemic control.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717288


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Novo Nordisk A/S
Investigators
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Principal Investigator: Kathleen M Dungan, MD Ohio State University
More Information
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Responsible Party: Kathleen Dungan, Assistant Professor of Medicine, Ohio State University
ClinicalTrials.gov Identifier: NCT00717288    
Other Study ID Numbers: 2007H0210
60016576 ( Other Identifier: Other )
First Posted: July 17, 2008    Key Record Dates
Results First Posted: October 3, 2011
Last Update Posted: October 3, 2011
Last Verified: August 2011
Keywords provided by Kathleen Dungan, Ohio State University:
diabetes
hyperglycemia
open heart surgery
cardiothoracic surgery
 detemir
insulin infusion
intravenous insulin
Additional relevant MeSH terms:
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Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs