NCT00095446

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
513

participants targeted

Target at P75+ for phase_4 diabetes

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_4 diabetes

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
4 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

November 4, 2004

Last Update Submit

January 2, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Keywords

Diabetes MellitusDiabetes

Outcome Measures

Primary Outcomes (1)

  • Treatment satisfaction with insulin pump therapy

Secondary Outcomes (5)

  • body weight

  • Insulin dose

  • Overall glycemic control

  • number and types of infusion sets used.

  • infusion set in-use times

Interventions

insulin aspartDRUG

Eligibility Criteria

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

You may qualify if:

  • People with Type I or Type II Diabetes
  • Years or Older.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Princeton, New Jersey, 08540, United States

Location

Related Publications (1)

  • Wittlin SD, Marcus AO, Weng CS, Howard CP, Schorr AB; CONTROL Study Group. Evaluation of treatment satisfaction associated with the use of insulin aspart in continuous subcutaneous insulin infusion. Diabetes Technol Ther. 2008 Feb;10(1):1-10. doi: 10.1089/dia.2007.0234.

    PMID: 18275357RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose 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

Study Officials

  • Global Clinical Registry (GCR,1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2004

First Posted

November 5, 2004

Study Start

July 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

US(1)