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
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Delivery Systems
Device: FlexPen®
Device: vial and syringe
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: July 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127296

Locations
United States, Texas
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Rogelio Braceras, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00127296     History of Changes
Other Study ID Numbers: BIASP-1654
Study First Received: August 3, 2005
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014