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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00127296
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 29.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jul 1, 2005
• Actual Primary Completion Date: Sep 1, 2005
• Actual Study Completion Date: Sep 1, 2005

Outcome Measures

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) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 99 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00127296
• Other Study ID Numbers: BIASP-1654
• First Posted: Aug 5, 2005
• Last Update Posted: Jan 6, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 6, 2017