A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.

NCT ID: NCT00437489

Last Updated: 2009-05-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Group Type ACTIVE_COMPARATOR

Inhaled Human Insulin (Exubera)

Intervention Type DRUG

Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID

Experimental

Group Type EXPERIMENTAL

Inhaled Human Insulin (Exubera)

Intervention Type DRUG

Initial dose of 1mg TID of inhaled human insulin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inhaled Human Insulin (Exubera)

Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID

Intervention Type DRUG

Inhaled Human Insulin (Exubera)

Initial dose of 1mg TID of inhaled human insulin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diabetes mellitus Type 2
* Currently treated with at least 2 oral anti-diabetic agents

Exclusion Criteria

* Severe Asthma, severe COPD
* Smoking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Hong Kong, , Hong Kong

Site Status

Pfizer Investigational Site

Karachi, Sindh, Pakistan

Site Status

Pfizer Investigational Site

Makati, , Philippines

Site Status

Pfizer Investigational Site

Marikina City, , Philippines

Site Status

Pfizer Investigational Site

Pasay, , Philippines

Site Status

Pfizer Investigational Site

Pasig, , Philippines

Site Status

Pfizer Investigational Site

Quezon City, , Philippines

Site Status

Pfizer Investigational Site

Singapore, , Singapore

Site Status

Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong Pakistan Philippines Singapore

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A2171086

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

US Inhaled Insulin Dose Titration Study
NCT00246623 COMPLETED PHASE3
Follow-Up Study for Exubera
NCT00734591 COMPLETED