Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes

NCT ID: NCT00590226

Last Updated: 2014-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-04-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Detemir + aspart insulin before meals

Intervention Type: DRUG

Detemir insulin SQ once daily + aspart insulin SQ before meals

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

Group Type: ACTIVE_COMPARATOR

NPH insulin + regular insulin

Intervention Type: DRUG

NPH insulin SQ + regular insulin SQ before breakfast and dinner

Interventions

Detemir + aspart insulin before meals

Detemir insulin SQ once daily + aspart insulin SQ before meals

Intervention Type: DRUG

NPH insulin + regular insulin

NPH insulin SQ + regular insulin SQ before breakfast and dinner

Intervention Type: DRUG

Other Intervention Names

levemir; novolog; novolin N; novolin R

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Baldwin, MD

Role: STUDY_CHAIR

Rush University Medical Center

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19017758 (View on PubMed)

Other Identifiers

791-2006

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00048954

Identifier Type: -

Identifier Source: org_study_id