US Inhaled Insulin Therapeutic Choice Questionnaire Study

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00139763
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Study Completion: 2006-03
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-15
• Last Update Posted: 2007-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 740

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Milwaukee, Wisconsin, United States