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

NCT01153100 | Completed Phase 1 FDA Drug

• 1 other identifier: 09-1065
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl)

  within 48 hours of discontinuation

Secondary Outcomes (4)

• 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

• Reduction in ICU length of stay

  within two weeks of hospitalization

• Equal or improved diabetes control

  within two weeks of hospitalization

• Reduction in time to get back to control of glycemia (140-180 mg/dl) if rebound hyperglycemia occurs

  within one week post insulin drip

Study Arms (2)

Standard insulin drip therapy

NO INTERVENTION

Standard insulin drip therapy

Insulin drip and glargine

ACTIVE COMPARATOR

Insulin drip and glargine 0.25 units per kg body weight

Drug: Glargine

Interventions

Glargine DRUG

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

Also known as: Lantus

Insulin drip and glargine

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Sanofi: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Boris Draznin, MD

  Univesity of Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 29, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)