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OpenTrials
Completed

NCT Number: NCT01153100

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glargine

Drug

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

Other names: Lantus

Primary outcomes

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

    Time frame: within 48 hours of discontinuation

Secondary outcomes

  1. 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

  2. Reduction in ICU length of stay

    Time frame: within two weeks of hospitalization

  3. Equal or improved diabetes control

    Time frame: within two weeks of hospitalization

  4. 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 29, 2010
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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