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

Diabetes Clinical Trial

Official title:

Effectiveness of a Subcutaneously Administered Long-acting Insulin Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153100
• Other study ID #: 09-1065
• Status: Completed
• Phase: Phase 1
• Start date: April 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Glargine
Glargine 0.25 units per kg body weight given every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl)		within 48 hours of discontinuation
Secondary	Reduction in duration of insulin drip therapy and reduction in total and average per hour insulin drip dose		within one week of insulin drip therapy
Secondary	Reduction in ICU length of stay		within two weeks of hospitalization
Secondary	Equal or improved diabetes control		within two weeks of hospitalization
Secondary	Reduction in time to get back to control of glycemia (140-180 mg/dl) if rebound hyperglycemia occurs		within one week post insulin drip