Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Compared With Vial and Syringe
Phase 1
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2Delivery Systems
- Registration Number
- NCT00127296
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference)
- Secondary Outcome Measures
Name Time Method Patient preference Accuracy (mean relative error) Precision (coefficient of variation)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸San Antonio, Texas, United States