Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Co... | NCT00127296

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

NCT00127296

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 6, 2017Estimated

Enrollment

60Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2
Delivery Systems

Interventions

FlexPen®
vial and syringe

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Sep 2005Actual

Completion Date

Sep 2005Actual

First Submitted Date

Aug 3, 2005

First Submission Date that Met QC Criteria

Aug 3, 2005

First Posted Date

Aug 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2017

Last Update Posted Date

Jan 6, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Patient preference
Accuracy (mean relative error)
Precision (coefficient of variation)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		San Antonio	Texas	78229	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2