MedTrace Logo

US Inhaled Insulin Dose Titration Study

NCT00246623 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-02-08

No results posted yet for this study

Summary

This study will examine how to dose Exubera (inhaled insulin) in patients who are not well controlled on two or more diabetes pills. This study should show that a large number of patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that have been set by the American Diabetes Association (ADA). Target goals should be achieved by adjusting the Exubera dose either weekly or twice weekly. Patients will also receive nutritional counseling and diabetes education as part of the study.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Exubera (inhaled insulin)

PROCEDURE

8-point glucose diary (to assess pre- and post prandial glucoses)

PROCEDURE

Meal Tolerance Test

PROCEDURE

24-hour continuous glucose monitoring (at select sites)

PROCEDURE

Pulmonary Function Testing

PROCEDURE

Hypoglycemic Event Monitoring

PROCEDURE

Laboratory Assessments

BEHAVIORAL

Nutritional Counseling and Diabetes Education

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Completion
2007-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00246623 on ClinicalTrials.gov