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 A/S
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

August 19, 2010
October 2, 2012
August 2010
August 2013   (final data collection date for primary outcome measure)
Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl) [ Time Frame: within 48 hours of discontinuation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01186003 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy
Effectiveness of a Subcutaneously Administered Long-Acting Insulin Detemir Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
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
  • 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
    Intervention: Drug: Detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
60
September 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
19 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01186003
10-0483
No
University of Colorado, Denver
University of Colorado, Denver
Novo Nordisk A/S
Principal Investigator: Boris Draznin, MD., Ph.D. University of Colorado, Denver
University of Colorado, Denver
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP