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Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01153100
First Posted: June 29, 2010
Last Update Posted: October 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
The investigators anticipate that the use of Glargine 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: Glargine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Subcutaneously Administered Long-acting Insulin Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment

Resource links provided by NLM:


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 ]

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 ]
  • Reduction in ICU length of stay [ Time Frame: within two weeks of hospitalization ]
  • Equal or improved diabetes control [ Time Frame: within two weeks of hospitalization ]
  • 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 ]

Enrollment: 60
Study Start Date: April 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard insulin drip therapy
Standard insulin drip therapy
Active Comparator: Insulin drip and glargine
Insulin drip and glargine 0.25 units per kg body weight
Drug: Glargine
Glargine 0.25 units per kg body weight given every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Other Name: Lantus

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre- and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutrition requiring insulin drip.
  • Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
  • Patients with both types of diabetes will be among those treated with the 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 drip 2 weeks and longer, pregnancy, Lantus allergy, and concurrent sulfonamide treatment
  Contacts and Locations
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): NCT01153100


Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Sanofi
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01153100     History of Changes
Other Study ID Numbers: 09-1065
First Submitted: June 14, 2010
First Posted: June 29, 2010
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by University of Colorado, Denver:
Diabetes

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs