Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Compared With Vial and Syringe

NCT ID: NCT00127296

Last Updated: 2017-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2 Delivery Systems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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FlexPen®

Intervention Type DEVICE

vial and syringe

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-1654

Identifier Type: -

Identifier Source: org_study_id

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