Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes

NCT00590226 | Completed Phase 4 Results DMC

• 2 other identifiers: IRB00048954791-2006
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Patients With Hypoglycemic Events

  during hospitalization

Study Arms (2)

detremir + aspart insulin

EXPERIMENTAL

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

NPH + regular insulin

ACTIVE COMPARATOR

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

Interventions

Detemir + aspart insulin before meals DRUG

Detemir insulin SQ once daily + aspart insulin SQ before meals

Also known as: levemir, novolog

detremir + aspart insulin

NPH insulin + regular insulin DRUG

NPH insulin SQ + regular insulin SQ before breakfast and dinner

Also known as: novolin N, novolin R

NPH + regular insulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Novo Nordisk A/S: collaborator

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related 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. J Clin Endocrinol Metab. 2009 Feb;94(2):564-9. doi: 10.1210/jc.2008-1441. Epub 2008 Nov 18.

  PMID: 19017758 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Detemir; Insulin Aspart; Insulin, Isophane; Insulin; Isophane Insulin, Human

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting; Proinsulin; Insulin, Regular, Human

Results Point of Contact

• Title: Guillermo Umpierrez, MD
• Organization: EUSOM

geumpie@emory.edu

4047781665

Study Officials

• David Baldwin, MD

  Rush University Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 10, 2008
• Study Start: December 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 11, 2014
• Results First Posted: June 11, 2014

Record last verified: 2014-05

Locations

US (2)