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OpenTrials
Completed

NCT Number: NCT01186003

Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy

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.

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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

Not applicable

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 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

Treatment and study plan

Detemir

Drug

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

Other names: Levimir

Primary outcomes

  1. Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)

    Time frame: within 48 hours of discontinuation

    Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl)

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

  • Novo Nordisk A/S

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2010
Registry last updated
Dec 7, 2021

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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