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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00127296

Enrollment

Registered

2005-08-05

Start date

2005-07-31

Completion date

2005-09-30

Last updated

2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery Systems, Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DEVICEFlexPen®

DEVICEvial and syringe

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Combined measure of accuracy and precision between target and measured amounts of insulin dispensed (mean square percent difference)	—

Secondary

Measure	Time frame
Patient preference	—
Accuracy (mean relative error)	—
Precision (coefficient of variation)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026