Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Kathleen Dungan, Ohio State University
ClinicalTrials.gov Identifier:
NCT00717288
First received: July 15, 2008
Last updated: August 30, 2011
Last verified: August 2011
  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).


Condition Intervention Phase
Diabetes Mellitus
Drug: Detemir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir.

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 [ Time Frame: day 2, day 3 ] [ Designated as safety issue: No ]
    Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3


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

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


Enrollment: 82
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717288

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Novo Nordisk A/S
Investigators
Principal Investigator: Kathleen M Dungan, MD Ohio State University
  More Information

No publications provided

Responsible Party: Kathleen Dungan, Assistant Professor of Medicine, Ohio State University
ClinicalTrials.gov Identifier: NCT00717288     History of Changes
Other Study ID Numbers: 2007H0210, 60016576
Study First Received: July 15, 2008
Results First Received: July 20, 2011
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University:
diabetes
hyperglycemia
open heart surgery
cardiothoracic surgery
detemir
insulin infusion
intravenous insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014