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NCT00127296 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Comparison of the Accuracy and Precision of NovoLog® Mix 70/30 FlexPen® to Vial and Syringe in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00127296
Other study ID # BIASP-1654
Secondary ID
Status Completed
Phase Phase 1
First received August 3, 2005
Last updated January 5, 2017
Start date July 2005
Est. completion date September 2005

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 2005
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender All
Age group 40 Years to 99 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Device:
• FlexPen®

• vial and syringe

Locations
Country Name City State
United States Novo Nordisk Investigational Site San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & 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

Outcome
Type Measure Description Time frame Safety issue
Primary Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference) No
Secondary Patient preference No
Secondary Accuracy (mean relative error) No
Secondary Precision (coefficient of variation) No
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