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Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Novo Nordisk
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01186003
First received: August 19, 2010
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

The investigators anticipate that the use of Detemir will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued.


Condition Intervention
Diabetes
 Drug: Detemir

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of a Subcutaneously Administered Long-Acting Insulin Detemir Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl) [ Time Frame: within 48 hours of discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in duration of insulin drip therapy and reduction in total and average per hour insulin drip dose [ Time Frame: within one week of insulin drip therapy ] [ Designated as safety issue: No ]
  • Reduction in ICU length of stay [ Time Frame: within two weeks of hospitalization ] [ Designated as safety issue: No ]
  • Equal or improved diabetes control [ Time Frame: within two weeks of hospitalization ] [ Designated as safety issue: No ]
  • Reduction in time to get back to control of glycemia (140-180 mg/dl) if rebound hyperglycemia occurs [ Time Frame: within one week post insulin drip ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard insulin drip therapy
Active Comparator: Insulin drip and Detemir
Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
 Drug: Detemir
Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Other Name: Levimir

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic ketoacidosis (DKA) and hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre-and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutritional requiring insulin drip.
  • Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
  • Patient with both types of diabetes will be among those treated with insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition
  • Patients will be of age 19 to 80.

Exclusion Criteria:

  • Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drop 2 weeks and longer, pregnancy, Levemir allergy, and concurrent sulfonamide treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186003

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Novo Nordisk
Investigators
Principal Investigator: Boris Draznin, MD., Ph.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01186003     History of Changes
Other Study ID Numbers: 10-0483
Study First Received: August 19, 2010
Last Updated: October 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Diabetes

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

ClinicalTrials.gov processed this record on May 16, 2013