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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
  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)

Secondary Outcome Measures:
  • Patient preference
  • Accuracy (mean relative error)
  • Precision (coefficient of variation)

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 to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
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
ClinicalTrials.gov Identifier: NCT00127296     History of Changes
Other Study ID Numbers: BIASP-1654
Study First Received: August 3, 2005
Last Updated: January 5, 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

ClinicalTrials.gov processed this record on April 24, 2017