NCT00177398

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

December 19, 2007

Status Verified

December 1, 2007

First QC Date

September 12, 2005

Last Update Submit

December 13, 2007

Conditions

Type 2 DiabetesHyperglycemia

Keywords

Type 2 diabetesHyperglycemiaEnteral nutrition

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

Glargine insulin vs regular insulinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

  • van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.

    PMID: 11794168BACKGROUND

  • Pancorbo-Hidalgo PL, Garcia-Fernandez FP, Ramirez-Perez C. Complications associated with enteral nutrition by nasogastric tube in an internal medicine unit. J Clin Nurs. 2001 Jul;10(4):482-90. doi: 10.1046/j.1365-2702.2001.00498.x.

    PMID: 11822496BACKGROUND

  • Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, Hirsch IB; American Diabetes Association Diabetes in Hospitals Writing Committee. Management of diabetes and hyperglycemia in hospitals. Diabetes Care. 2004 Feb;27(2):553-91. doi: 10.2337/diacare.27.2.553. No abstract available.

    PMID: 14747243BACKGROUND

  • Korytkowski MT, Salata RJ, Koerbel GL, Selzer F, Karslioglu E, Idriss AM, Lee KK, Moser AJ, Toledo FG. Insulin therapy and glycemic control in hospitalized patients with diabetes during enteral nutrition therapy: a randomized controlled clinical trial. Diabetes Care. 2009 Apr;32(4):594-6. doi: 10.2337/dc08-1436.

    PMID: 19336639DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mary T Korytkowski, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

February 1, 2005

Study Completion

August 1, 2006

Last Updated

December 19, 2007

Record last verified: 2007-12

Locations

US(1)