Effect of Glargine Insulin on Glucose Control in Hospitalized Patients Who Receive Tube Feedings

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177398
First received: September 12, 2005
Last updated: December 13, 2007
Last verified: December 2007
  Purpose

The purpose of this study is to determine if the early initiation of a long acting insulin (i.e. glargine) with supplemental doses of short acting regular (SSR) insulin in hospitalized patients with diabetes who are fed using tube feedings reduces the frequency of high and low blood sugar levels when compared to use of SSR insulin alone.


Condition Intervention Phase
Type 2 Diabetes
Hyperglycemia
Drug: Glargine insulin vs 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: The Effect of Insulin Glargine on Glycemic Control, Morbidity, and Length of Stay in Hospitalized Subjects With Diabetes Receiving Enteral Nutrition

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The primary outcome to be studied is the frequency and severity of hyperglycemia and hypoglycemia in each group
  • Time to mean 24 hour plasma glucose < 180 mg/dl

Secondary Outcome Measures:
  • Triglyceride level at study entry and conclusion
  • Hospital length of stay
  • Inpatient mortality
  • Number of days of antibiotic therapy
  • Number of days with recorded temperature >/= 100.4F
  • Occurrence of any of the following: MI, CHF, pneumonia, CVA, renal impairment (defined as serum creat > 2 mg/dl)
  • Quality of Life measures using MOS SF 36 General Health Survey
  • Outpatient glycemic control and self management practices

Estimated Enrollment: 50
Study Start Date: February 2005
Study Completion Date: August 2006
Detailed Description:

Hyperglycemia is one of the most frequently encountered complications of enteral nutrition therapy in the hospital setting. However, there is no standardized approach directed towards the identification and management of patients who develop hyperglycemia while receiving enteral nutrition. The primary aim of the study is to determine if the early initiation of subcutaneous glargine insulin with supplemental doses of sliding scale human regular (SSR) insulin in hospitalized subjects with diabetes receiving enteral nutrition reduces the frequency of hyperglycemia and hypoglycemia when compared to use of SSR insulin alone.

In this proposal, we plan to investigate a strategy of early insulin therapy in the management of hospitalized subjects with diabetes mellitus who develop hyperglycemia defined as two blood glucose (BG) measurements greater than 130 mg/dl within 48 hours prior to or within a 48 hour period during enteral nutrition therapy.

The study is a phase IV, investigator initiated randomized, parallel group clinical trial. Potential subjects will include those subjects with written orders for initiation of enteral feedings using a formula containing carbohydrates. Consented subjects will have bedside glucose monitoring performed every 6 hours for the first 48 hours following initiation of enteral nutrition to determine if hyperglycemia occurs. To determine a difference in mean plasma glucose of 25 mg/dl and hospital LOS of 4 days between the two groups with an of 0.01 with power of 0.9, 25 subjects will be randomized to each group (total of 50 subjects). Baseline and outcome variables between the two groups will be compared using Student's t-testing, chi-square analysis, and the Mann-Whitney U test.

Group 1 will receiving a single daily dose of glargine insulin along with sliding scale regular human (SSR) insulin titrated according to blood glucose results. Group 2 will receive only sliding scale human regular (SSR) insulin titrated according to an algorithm. Both groups will be followed daily until enteral feedings are discontinued or for a maximum of three weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes defined according to ADA criteria
  • Enteral nutrition therapy
  • Two blood glucose readings > 130 mg/dl within 48-hrs prior to or within a 48-hour period during enteral nutrition therapy
  • Men and women age >/= 18
  • Ability for patient or legally authorized representative to understand and sign an informed consent document

Exclusion Criteria:

  • Subjects with conditions that are anticipated to have short term (i.e. < 2 months survival) based on discussions with the treatment team and attending physician.
  • Subjects admitted to the CT ICU or any unit with pre-established protocols for glycemic management.
  • Subjects with known type 1 diabetes (who will absolutely require a long or intermediate acting insulin preparation).
  • Subjects with known type 2 diabetes who currently receive 30 units or more of an intermediate or long acting insulin.
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177398

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Sanofi
Investigators
Principal Investigator: Mary T Korytkowski, MD University of Pittsburgh
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00177398     History of Changes
Other Study ID Numbers: IRB0408186
Study First Received: September 12, 2005
Last Updated: December 13, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Type 2 diabetes
Hyperglycemia
Enteral nutrition

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014