Skip to main content
OpenTrials
Completed

NCT Number: NCT00127296

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FlexPen®

Device

vial and syringe

Device

Primary outcomes

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

Secondary outcomes

  1. Patient preference

  2. Accuracy (mean relative error)

  3. Precision (coefficient of variation)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Comparison of the Accuracy and Precision of NovoLog® Mix 70/30 FlexPen® to Vial and Syringe in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Aug 5, 2005
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.