CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,976 enrolled
Drug / intervention
Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00359801
NCT00359801Phase 4Completed
CompareCT.gov

An International, Multicenter, Large Simple Trial To Evaluate The Long-Term Pulmonary And Cardiovascular Safety Of Exubera In Patients With Diabetes Mellitus

Pfizer·interventional·Posted Aug 2, 2006·Updated Feb 2, 2010

In Brief

A Phase 4 clinical trial evaluating Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care for Diabetes Mellitus. Completed, enrolled 1,976 participants across 197 sites in 5 countries.

Detailed Summary

The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesGermany, Puerto Rico, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2, 2006
Enrollment StartJul 1, 2006
Primary CompletionDec 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 19.9 years ago

Interventions

Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Caredrug

Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions.

Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Caredrug

Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).