NCT00338104

Brief Summary

The primary objective of this study is to determine the optimal dose of glargine insulin when converting from intravenous short-acting continuous insulin infusions in surgical and intensive care unit patients using a prospective, controlled, parallel group, randomized study design. Note: Lantus insulin is the proprietary name for glargine insulin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_4

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

July 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 6, 2009

Completed
Last Updated

April 6, 2009

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

June 15, 2006

Results QC Date

December 1, 2008

Last Update Submit

April 3, 2009

Conditions

HyperglycemiaDiabetes

Keywords

insulinglargineintravenoussubcutaneoushospitaldiabetesglucoseinpatient

Outcome Measures

Primary Outcomes (1)

  • Percentage of Blood Glucose Values Between 80 - 140

    Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL

    First 24 hours after conversion

Secondary Outcomes (2)

  • Percentage of Glucose Values < 50 mg/dL

    First 24 hours after conversion

  • Percentage of Glucose Levels > 180 mg/dL

    First 24 hours after conversion

Study Arms (3)

40% Glargine

EXPERIMENTAL

Patients will receive a dose of glargine insulin equal to 40% of insulin drip rate.

Drug: insulin glargine

60% Glargine

EXPERIMENTAL

Patients will receive a dose of glargine insulin equal to 60% of insulin drip rate.

Drug: insulin glargine

80% Glargine

EXPERIMENTAL

Patients will receive a dose of glargine insulin equal to 80% of insulin drip rate.

Drug: insulin glargine

Interventions

insulin glargineDRUG

Insulin glargine given at 40% of prior stable drip rate.

Also known as: Lantus is brand name for Glargine
40% Glargine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting glucose \> 100 mg/dl
  • Patients on surgical services or in intensive care units receiving intravenous insulin

You may not qualify if:

  • Inability to obtain informed consent from patient or next-of-kin
  • Allergy to insulin
  • Participation in another research study
  • Patients for whom there are "do-not-resuscitate" orders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Schmeltz LR, DeSantis AJ, Schmidt K, O'Shea-Mahler E, Rhee C, Brandt S, Peterson S, Molitch ME. Conversion of intravenous insulin infusions to subcutaneously administered insulin glargine in patients with hyperglycemia. Endocr Pract. 2006 Nov-Dec;12(6):641-50. doi: 10.4158/EP.12.6.641.

    PMID: 17229660RESULT

MeSH Terms

Conditions

HyperglycemiaDiabetes MellitusInsulin Resistance

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

not all patients were analyzed in each group because insulin not given appropriately to those patients

Results Point of Contact

Title
Mark E. Molitch, M.D.
Organization
Northwestern University
molitch@northwestern.edu
312 503-4130

Study Officials

  • Mark E Molitch, M.D.

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

July 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

April 6, 2009

Results First Posted

April 6, 2009

Record last verified: 2009-03

Locations

US(1)