A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

April 1, 2019 updated by: Pfizer

A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents

To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
354

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Gain Medical Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 1A2
        • Misericordia Health Centre
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4X7
        • Maritime Research Center
    • Ontario
      • London, Ontario, Canada, N6P 1A9
        • Office of Dr. Salim Sunderji
      • Orillia, Ontario, Canada, L3V 2Z6
        • Orillia Soldier's Memorial Hospital
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 1L2
        • Douglas Tweel M.D. Professional Corporation
    • Quebec
      • Bonaventure, Quebec, Canada, G0C 1E0
        • Laboratoire Sante Le Gaspesien Inc.
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire
      • Drummondville, Quebec, Canada, J2B 1H8
        • Rhodin Recherche Clinique
      • Gatineau, Quebec, Canada, J8Y 6S9
        • Q & T Research Outaouais Inc.
      • Greenfield Park, Quebec, Canada, J4V2H1
        • Hopital Charles LeMoyne
      • Saint-Foy, Quebec, Canada, G1V 4G5
        • Hôpital Laval
      • St-Marc-des-Carrieres, Quebec, Canada, G0A 4B0
        • Centre Medical des Carrieres
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • CIC Mauricie inc.
  • France
      • Amiens cedex 1, France, 80094
        • Groupe Hospitalier Sud/Service d'Endocrinologie
      • Armentieres, France, 59427
        • Private Practise
      • Bondy Cedex, France, 93143
        • Service d'Endocrinologie-
      • Brest CEDEX, France, 29609
        • Hopital LA Cavale Blanche, Service de Diabetologie
      • Cean Cedex, France, 14033
        • CHU Cote de Nacre, Service d'Endocrinologie
      • Chartres, France, 28000
        • Private Practise
      • Lille, France, 59000
        • Office of Antoine Lemaire, MD
      • Lorient Cedex, France, 56322
        • Centre Hospitalier Bretagne Sud
      • Montpellier CEDEX 5, France, 34295
        • Hopital Lapeyronnie Sce des Maladies
      • Paris, France, 75015
        • Hopital Saint Michel
      • Paris Cedex 18, France, 75877
        • Hopital Bichat, Service d'Endocrinology
      • Reims, France, 51100
        • Hopital Robert Debre
      • Rennes, France, 35056
        • C.H. Sud, Diabetologie
      • Roubaix, France, 59100
        • Centre hospitalier Victor Provo
      • Toul Cedex, France, 54201
        • Hôpital Jeanne d'Arc - Dommartin les Toul
    • Cedex 01
      • Nantes, Cedex 01, France, F-44035
        • Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition
  • Greece
      • Athens, Greece, 11527
        • General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic
      • Athens, Greece, 151 23
        • "Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic
      • Haidari, Greece, 124 62
        • "ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic
      • Pireaus, Greece, 18454
        • Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department
      • Thessaloniki, Greece, 546 36
        • University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin
  • Portugal
      • Aveiro, Portugal, 3814-096
        • Hospital Infante D. Pedro
      • Coimbra, Portugal, 3000-075
        • Hospitais da universidade de Coimbra
      • Lisboa, Portugal, 1250-203
        • Associação Protectora dos Diabéticos de Portugal
      • Lisboa, Portugal, 1300
        • Serviço de Endocrinologia - Hospital de Egas Moniz
      • Porto, Portugal, 4099-001
        • Hospital Geral de Santo Antonio
      • Torres Vedras, Portugal, 2560-324
        • Centro Hospitalar de Torres Vedras
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08035
        • Hospital General Universitario Valle de Hebron
      • Madrid, Spain, 28035
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28935
        • Hospital De Mostoles
      • Malaga, Spain, 29009
        • Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C
      • Pontevedra, Spain, 36071
        • Hospital Montecelo
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46009
        • Hospital Universitario la Fe
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario Lozano Blesa
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Hospital Clínico Universitario de Santiago
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Hospital de Conxo
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Hospital Universitario Central de Asturias
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital De Bellvitge
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Mútua de Terrassa
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra
  • Sweden
      • Stockholm, Sweden, 118 83
        • Södersjukhuset
      • Stockholm, Sweden, 141 86
        • Karolinska US Huddinge
      • Ängelholm, Sweden, 262 81
        • Ängelholms sjukhus
  • Turkey
      • Anakara, Turkey
        • Hacettepe University Medical School Department of Endocrinology
      • Istanbul, Turkey, 34390
        • Istanbul University Istanbul Medical School, Department of Endocrinology
      • Izmir, Turkey, 35340
        • Dokuz Eylul University Medical School, Department of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes mellitus type 2
  • Failing two or more oral anti-diabetic agents

Exclusion Criteria:

  • Asthma, COPD
  • Smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Inhaled Insulin
Inhaled insulin plus oral therapy
Drug: Inhaled Insulin (Exubera)
Addition of inhaled insulin to pre-existing oral diabetes therapy.
Other: Standard of Care
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Other: Standard of Care
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Time Frame: 4, 12 and 24 weeks
[(week 24 value - baseline value)/baseline value]*100%
4, 12 and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Glycemic Control by Visit
Time Frame: 4, 12 and 24 weeks
2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%
4, 12 and 24 weeks
Change From Baseline in FEV1 at Week 24 LOCF
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 19, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A2171063
  • EXACTA (Other Identifier: Alias Study Number)
  • 2005-003504-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus Type 2

Clinical Trials on Inhaled Insulin (Exubera)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings