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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

354

Phase

  • 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
        • Associacao Protectora dos Diabeticos 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 Fé
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Hospital Clinico 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 Mutua 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

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
Intervention / Treatment
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

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

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

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)

March 6, 2006

Primary Completion (Actual)

February 19, 2008

Study Completion (Actual)

February 19, 2008

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (Estimate)

January 27, 2006

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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