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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Detemir + aspart insulin before meals

NPH insulin + regular insulin

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes, inpatient hyperglycemia, SQ insulin, Hospitalized patients with type 2 diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or females between the ages of 18 and 70 years admitted to a general medical service.
A known history of type 2 diabetes mellitus > 3 months, receiving any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy.
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:

Subjects with increased blood glucose concentration, but without a known history of diabetes.
Subjects with a history of acute hyperglycemic crises such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [63].
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.
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.
History of drug or alcohol abuse within the last 2 years.
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism.
Female subjects are pregnant or breast feeding at time of enrollment into the study.

Sites / Locations

Grady Memorial Hospital
Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

detremir + aspart insulin

NPH + regular insulin

Arm Description

Detemir insulin once daily + aspart insulin before meals three times a day at an initial total dose of 0.5 units/kg/day, subcutaneously

NPH insulin once a day + regular insulin before breakfast and dinner at an initial total dose of 0.5 units/kg/day, subcutaneously

Outcomes

Primary Outcome Measures

Mean AM BG (mg/dl)

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

number of patients with hypoglycemic events as defined as BG 40-59 mg/dl

Full Information

NCT ID

NCT00590226

First Posted

December 27, 2007

Last Updated

June 6, 2014

Sponsor

Emory University

Collaborators

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT00590226

Brief Title

Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes

Acronym

DEAN

Official Title

Comparative Trial Between Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

type 2 diabetes, inpatient hyperglycemia, SQ insulin, Hospitalized patients with type 2 diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

detremir + aspart insulin

Arm Type

Experimental

Arm Description

Detemir insulin once daily + aspart insulin before meals three times a day at an initial total dose of 0.5 units/kg/day, subcutaneously

Arm Title

NPH + regular insulin

Arm Type

Active Comparator

Arm Description

NPH insulin once a day + regular insulin before breakfast and dinner at an initial total dose of 0.5 units/kg/day, subcutaneously

Intervention Type

Drug

Intervention Name(s)

Detemir + aspart insulin before meals

Other Intervention Name(s)

levemir, novolog

Intervention Description

Detemir insulin SQ once daily + aspart insulin SQ before meals

Intervention Type

Drug

Intervention Name(s)

NPH insulin + regular insulin

Other Intervention Name(s)

novolin N, novolin R

Intervention Description

NPH insulin SQ + regular insulin SQ before breakfast and dinner

Primary Outcome Measure Information:

Title

Mean AM BG (mg/dl)

Description

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

Time Frame

during hospitalization

Secondary Outcome Measure Information:

Title

Number of Patients With Hypoglycemic Events

Description

number of patients with hypoglycemic events as defined as BG 40-59 mg/dl

Time Frame

during hospitalization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females between the ages of 18 and 70 years admitted to a general medical service. A known history of type 2 diabetes mellitus > 3 months, receiving any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy. 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: Subjects with increased blood glucose concentration, but without a known history of diabetes. Subjects with a history of acute hyperglycemic crises such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [63]. 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. 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. History of drug or alcohol abuse within the last 2 years. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism. Female subjects are pregnant or breast feeding at time of enrollment into the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Baldwin, MD

Organizational Affiliation

Rush University Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Grady Memorial Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19017758

Citation

Umpierrez GE, Hor T, Smiley D, Temponi A, Umpierrez D, Ceron M, Munoz C, Newton C, Peng L, Baldwin D. Comparison of inpatient insulin regimens with detemir plus aspart versus neutral protamine hagedorn plus regular in medical patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Feb;94(2):564-9. doi: 10.1210/jc.2008-1441. Epub 2008 Nov 18.

Results Reference

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Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes

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