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Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes (DEAN)

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ClinicalTrials.gov Identifier: NCT00590226
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. Recently, the use of basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart, glulisine) has been shown to facilitate outpatient glycemic control with lower rate of hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will determine the efficacy and safety of the combination of detemir and aspart insulin in the inpatient management of subjects with diabetes. We hypothesize that in patients with type 2 diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA.

This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will serve as principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at the Rush University Medical Center, Chicago, IL.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Detemir + aspart insulin before meals Drug: NPH insulin + regular insulin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Trial Between Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Type 2 Diabetes
Study Start Date : December 2006
Primary Completion Date : January 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: detremir + aspart insulin
Detemir insulin once daily + aspart insulin before meals three times a day at an initial total dose of 0.5 units/kg/day, subcutaneously
Drug: Detemir + aspart insulin before meals
Detemir insulin SQ once daily + aspart insulin SQ before meals
Other Names:
  • levemir
  • novolog
Active Comparator: NPH + regular insulin
NPH insulin once a day + regular insulin before breakfast and dinner at an initial total dose of 0.5 units/kg/day, subcutaneously
Drug: NPH insulin + regular insulin
NPH insulin SQ + regular insulin SQ before breakfast and dinner
Other Names:
  • novolin N
  • novolin R

Outcome Measures

Primary Outcome Measures :
  1. Mean AM BG (mg/dl) [ Time Frame: during hospitalization ]
    average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2

Secondary Outcome Measures :
  1. Number of Patients With Hypoglycemic Events [ Time Frame: during hospitalization ]
    number of patients with hypoglycemic events as defined as BG 40-59 mg/dl

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males or females between the ages of 18 and 70 years admitted to a general medical service.
  2. A known history of type 2 diabetes mellitus > 3 months, receiving any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy.
  3. Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL and no evidence of ketoacidosis (serum bicarbonate < 18 mEq/L, venous or arterial pH < 7.30, positive serum or urinary ketones).

Exclusion Criteria:

  1. Subjects with increased blood glucose concentration, but without a known history of diabetes.
  2. Subjects with a history of acute hyperglycemic crises such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [63].
  3. Patients with acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), or to undergo surgery during the hospitalization course.
  4. Patients with clinically relevant hepatic disease (ALT 2.5x > upper limit of normal), or impaired renal function, as shown by a serum creatinine ≥2.0 mg/dL for males, or ≥ 1.8 mg/dL for females.
  5. History of drug or alcohol abuse within the last 2 years.
  6. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  7. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism.
  8. Female subjects are pregnant or breast feeding at time of enrollment into the study.
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): NCT00590226

United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Emory University
Novo Nordisk A/S
Study Chair: David Baldwin, MD Rush University Medical Center
More Information

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00590226     History of Changes
Other Study ID Numbers: IRB00048954
791-2006 ( Other Identifier: Other )
First Posted: January 10, 2008    Key Record Dates
Results First Posted: June 11, 2014
Last Update Posted: June 11, 2014
Last Verified: May 2014

Keywords provided by Guillermo Umpierrez, Emory University:
type 2 diabetes
inpatient hyperglycemia
SQ insulin
Hospitalized patients with type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin degludec, insulin aspart drug combination
Insulin Aspart
Insulin Detemir
Insulin, Isophane
Isophane Insulin, Human
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs