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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127296
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : January 6, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : July 2005
Primary Completion Date : September 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference)

Secondary Outcome Measures :
  1. Patient preference
  2. Accuracy (mean relative error)
  3. Precision (coefficient of variation)

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127296

United States, Texas
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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

Responsible Party: Novo Nordisk A/S Identifier: NCT00127296     History of Changes
Other Study ID Numbers: BIASP-1654
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs