NCT00461331

Brief Summary

The purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2004

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 19, 2011

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

2.7 years

First QC Date

April 16, 2007

Results QC Date

May 12, 2009

Last Update Submit

January 6, 2021

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitusGlycemic controlContinuous subcutaneous insulin infusionContinuous glucose monitoring system

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change

    For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level \>300 mg/dL.

    24 to 100 hours after last pump infusion line change

Secondary Outcomes (2)

  • Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place

    48 to 100 hours after keeping the same pump infusion line in place

  • Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place

    Between 48, 72 and 96 hours after the last pump infusion line change

Study Arms (2)

Insulin 1

ACTIVE COMPARATOR

Either insulin Aspart or insulin Lispro were randomized to be insulin 1.

Drug: Insulin Aspart

Insulin 2

ACTIVE COMPARATOR

Between insulin Aspart and insulin Lispro, the one that was not used as insulin 1 was then used as the second insulin for the second arm of the study.

Drug: Insulin Lispro

Interventions

Insulin AspartDRUG

Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study.

Also known as: Insulin lispro - insulin Humalog, Insulin aspart - insulin Novolog
Insulin 1
Insulin LisproDRUG

Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.

Also known as: Insulin Aspart
Insulin 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 Diabetes treated with a pump for at least 3 months

You may not qualify if:

  • Pregnancy
  • Plasma Creatinine \> 1.2 mg/dl
  • Inability to give informed consent
  • HbA1c \> 8%
  • Known or suspected hypersensitivity to trial drugs or any of their components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Translational Unit - Tulane School of Medicine

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin AspartInsulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Tina K. Thethi, MD, MPH
Organization
Tulane University Health Sciences Center
tthethi@tulane.edu
504-988-5044

Study Officials

  • Vivian A Fonseca, MD, FRCP

    Tulane Universtiy Health Sciences Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 18, 2007

Study Start

October 1, 2004

Primary Completion

June 1, 2007

Study Completion

August 1, 2008

Last Updated

January 8, 2021

Results First Posted

May 19, 2011

Record last verified: 2021-01

Locations

US(1)