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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00127296
First received: August 3, 2005
Last updated: January 5, 2017
Last verified: January 2017
August 3, 2005
January 5, 2017
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)
Same as current
Complete list of historical versions of study NCT00127296 on ClinicalTrials.gov Archive Site
  • Patient preference
  • Accuracy (mean relative error)
  • Precision (coefficient of variation)
  • Precision (coefficient of variation)
  • Accuracy (mean relative error)
  • Patient preference
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
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

*   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
Sexes Eligible for Study: All
40 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00127296
BIASP-1654
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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