Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes

Type 2 Diabetes Clinical Trial

— DEAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590226
• Other study ID #: IRB00048954
• Secondary ID: 791-2006
• Status: Completed
• Phase: Phase 4
• First received: December 27, 2007
• Last updated: June 6, 2014
• Start date: December 2006
• Est. completion date: April 2008

Study information

• Verified date: May 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Detemir + aspart insulin before meals
Detemir insulin SQ once daily + aspart insulin SQ before meals
• NPH insulin + regular insulin
NPH insulin SQ + regular insulin SQ before breakfast and dinner

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during hospitalization	Yes
Secondary	Number of Patients With Hypoglycemic Events	number of patients with hypoglycemic events as defined as BG 40-59 mg/dl	during hospitalization	Yes