US Inhaled Insulin Therapeutic Choice Questionnaire Study

This study has been completed.

Sponsor:

Collaborator:

Sanofi

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00139763

First received: August 29, 2005

Last updated: March 15, 2007

Last verified: March 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

August 29, 2005

Last Updated Date

March 15, 2007

Start Date ^ICMJE

July 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Will availability of inhaled insulin result in more type 2 diabetes patients choosing a treatment that involves insulin (if now on >2 OAs) or a more intensive insulin regimen (if now on OAs + glargine) compared to only standard therapies available

Original Primary Outcome Measures ^ICMJE

Type 2 diabetic patients suboptimally controlled on >= 2 oral agents.
- Determine whether the availability of inhaled insulin will result in more patients willing to choose a treatment option that involves insulin compared to patients for whom only the s

Change History

Complete list of historical versions of study NCT00139763 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Determine both patient and MD reasons for treatment choices made. Determine if treatment choice is influenced by physician specialty or patient ethnicity. Determine how cost impacts patient treatment choice.

Original Secondary Outcome Measures ^ICMJE

- Determine influences on treatment choice based on physician specialty, patient demographics, patient diabetes history, and/or patient metabolic control
- Determine the patient's and physician's reason why the choice of therapy was made
- Determine if t

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

US Inhaled Insulin Therapeutic Choice Questionnaire Study

Official Title ^ICMJE

A US Randomized Questionnaire-Based Trial Assessing The Impact Of The Availability Of Inhaled Insulin On Therapeutic Choice In Patients With Suboptimally Controlled Type 2 Diabetes

Brief Summary

This is a questionnaire based study (no study drug is involved) that asks if more patients with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment choice if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments.

This study will also ask if patients with uncontrolled type 2 diabetes currently managed on diabetes pills + once daily insulin will choose as the next treatment choice to take insulin multiple times a day if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Procedure: Educational Materials

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

740

Estimated Completion Date

March 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male and female, age > = 18 years and <= 80 years with a diagnosis of type 2 diabetes made at least 6 months prior to study entry
Currently treated with either:
2 or more oral antidiabetic agents, OR 1 or more oral antidiabetic agents and insulin glargine

Exclusion Criteria:

Type 1 diabetes
Smoking within the past 6 months

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00139763

Other Study ID Numbers ^ICMJE

A2171066

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Sanofi

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

Pfizer

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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