NCT00127296

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare desired (target) with actual target amounts of insulin dispensed using NovoLog® Mix 70/30 FlexPen® and vial and syringe in subjects with type 2 diabetes mellitus. No insulin is administered in this trial - insulin is dispensed into an empty vial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_1 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, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

August 3, 2005

Last Update Submit

January 5, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2Delivery Systems

Outcome Measures

Primary Outcomes (1)

  • Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference)

Secondary Outcomes (3)

  • Patient preference

  • Accuracy (mean relative error)

  • Precision (coefficient of variation)

Interventions

FlexPen®DEVICE
vial and syringeDEVICE

Eligibility Criteria

Age40 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Insulin naive
  • No previous experience administering injections

You may not qualify if:

  • Any condition that, in the Investigator and/or Sponsor's opinion, could interfere with the results of this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Schwartz S, Khutoryansky N, Braceras R. Comparison of resource utilisation, preference and handling of a pre-filled pen and vial/syringe in patients with type 2 diabetes mellitus. Journal of Clinical Research 2007; 10: 1-10

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Syringes

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2005

First Posted

August 5, 2005

Study Start

July 1, 2005

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

US(1)