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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00127296
First received: August 3, 2005
Last updated: April 12, 2013
Last verified: April 2013

August 3, 2005
April 12, 2013
July 2005
September 2005   (final data collection date for primary outcome measure)
Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference) [ Designated as safety issue: No ]
Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference)
Complete list of historical versions of study NCT00127296 on ClinicalTrials.gov Archive Site
  • Patient preference [ Designated as safety issue: No ]
  • Accuracy (mean relative error) [ Designated as safety issue: No ]
  • Precision (coefficient of variation) [ Designated as safety issue: No ]
  • Patient preference
  • Accuracy (mean relative error)
  • Precision (coefficient of variation)
Not Provided
Not Provided
 
Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Compared With Vial and Syringe
Comparison of the Accuracy and Precision of NovoLog® Mix 70/30 FlexPen® to Vial and Syringe in Patients With Type 2 Diabetes Mellitus

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Delivery Systems
  • Device: FlexPen®
  • Device: vial and syringe
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2005
September 2005   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00127296
BIASP-1654
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Rogelio Braceras, MD Novo Nordisk A/S
Novo Nordisk A/S
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP