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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00590226
First received: December 27, 2007
Last updated: June 6, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes
Drug: Detemir + aspart insulin before meals
Drug: NPH insulin + regular insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Trial Between Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Mean AM BG (mg/dl) [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]
    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:
  • Number of Patients With Hypoglycemic Events [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]
    number of patients with hypoglycemic events as defined as BG 40-59 mg/dl


Enrollment: 130
Study Start Date: December 2006
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00590226

Locations
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
Investigators
Study Chair: David Baldwin, MD Rush University Medical Center
  More Information

Publications:
Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00590226     History of Changes
Other Study ID Numbers: IRB00048954, 791-2006
Study First Received: December 27, 2007
Results First Received: November 12, 2013
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin, Isophane
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014