Study Stopped
Terminated as marketing of this product will be discontinued
A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus
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
3 other identifiers
interventional
354
7 countries
64
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Mar 2006
Typical duration for phase_3 diabetes-mellitus-type-2
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2006
CompletedFirst Posted
Study publicly available on registry
January 27, 2006
CompletedStudy Start
First participant enrolled
March 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2008
CompletedResults Posted
Study results publicly available
August 26, 2009
CompletedApril 2, 2019
April 1, 2019
2 years
January 26, 2006
February 11, 2009
April 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
\[(week 24 value - baseline value)/baseline value\]\*100%
4, 12 and 24 weeks
Secondary Outcomes (2)
Percentage of Participants Achieving Glycemic Control by Visit
4, 12 and 24 weeks
Change From Baseline in FEV1 at Week 24 LOCF
24 weeks
Study Arms (2)
Inhaled Insulin
EXPERIMENTALInhaled insulin plus oral therapy
Standard of Care
OTHERStandard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Interventions
Addition of inhaled insulin to pre-existing oral diabetes therapy.
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Eligibility Criteria
You may qualify if:
- Diabetes mellitus type 2
- Failing two or more oral anti-diabetic agents
You may not qualify if:
- Asthma, COPD
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (64)
Gain Medical Center
Coquitlam, British Columbia, V3K 3P4, Canada
Misericordia Health Centre
Winnipeg, Manitoba, R3C 1A2, Canada
Maritime Research Center
Bathurst, New Brunswick, E2A 4X7, Canada
Office of Dr. Salim Sunderji
London, Ontario, N6P 1A9, Canada
Orillia Soldier's Memorial Hospital
Orillia, Ontario, L3V 2Z6, Canada
Douglas Tweel M.D. Professional Corporation
Charlottetown, Prince Edward Island, C1A 1L2, Canada
Laboratoire Sante Le Gaspesien Inc.
Bonaventure, Quebec, G0C 1E0, Canada
Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire
Chicoutimi, Quebec, G7H 5H6, Canada
Rhodin Recherche Clinique
Drummondville, Quebec, J2B 1H8, Canada
Q & T Research Outaouais Inc.
Gatineau, Quebec, J8Y 6S9, Canada
Hopital Charles LeMoyne
Greenfield Park, Quebec, J4V2H1, Canada
Hopital Laval
Saint-Foy, Quebec, G1V 4G5, Canada
Centre Medical des Carrieres
Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada
CIC Mauricie Inc.
Trois-Rivières, Quebec, G8T 7A1, Canada
Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition
Nantes, Cedex 01, F-44035, France
Groupe Hospitalier Sud/Service d'Endocrinologie
Amiens, 80094, France
Private Practise
Armentières, 59427, France
Service d'Endocrinologie-
Bondy, 93143, France
Hopital LA Cavale Blanche, Service de Diabetologie
Brest, 29609, France
CHU Cote de Nacre, Service d'Endocrinologie
Cean Cedex, 14033, France
Private Practise
Chartres, 28000, France
Office of Antoine Lemaire, MD
Lille, 59000, France
Centre Hospitalier Bretagne Sud
Lorient, 56322, France
Hopital Lapeyronnie Sce des Maladies
Montpellier, 34295, France
Hopital Saint Michel
Paris, 75015, France
Hopital Bichat, Service d'Endocrinology
Paris, 75877, France
Hopital Robert Debre
Reims, 51100, France
C.H. Sud, Diabetologie
Rennes, 35056, France
Centre Hospitalier Victor Provo
Roubaix, 59100, France
Hôpital Jeanne d'Arc - Dommartin les Toul
Toul, 54201, France
General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic
Athens, 11527, Greece
"Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic
Athens, 151 23, Greece
"ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic
Haidari, 124 62, Greece
Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department
Pireaus, 18454, Greece
University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin
Thessaloniki, 546 36, Greece
Hospital Infante D. Pedro
Aveiro, 3814-096, Portugal
Hospitais da Universidade de Coimbra
Coimbra, 3000-075, Portugal
Associação Protectora dos Diabéticos de Portugal
Lisbon, 1250-203, Portugal
Serviço de Endocrinologia - Hospital de Egas Moniz
Lisbon, 1300, Portugal
Hospital Geral de Santo António
Porto, 4099-001, Portugal
Centro Hospitalar de Torres Vedras
Torres Vedras, 2560-324, Portugal
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
Hospital de Conxo
Santiago de Compostela, A Coruña, 15706, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital General Universitario Valle de Hebron
Barcelona, 08035, Spain
Hospital Universitario Puerta de Hierro
Madrid, 28035, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital de Mostoles
Madrid, 28935, Spain
Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C
Málaga, 29009, Spain
Hospital Montecelo
Pontevedra, 36071, Spain
Hospital Universitario La Fe
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Ängelholms sjukhus
Ängelholm, 262 81, Sweden
Sodersjukhuset
Stockholm, 118 83, Sweden
Karolinska US Huddinge
Stockholm, 141 86, Sweden
Hacettepe University Medical School Department of Endocrinology
Ankara, Turkey (Türkiye)
Istanbul University Istanbul Medical School, Department of Endocrinology
Istanbul, 34390, Turkey (Türkiye)
Dokuz Eylul University Medical School, Department of Endocrinology
Izmir, 35340, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study terminated prematurely since the sponsor stopped marketing and manufacturing of EXUBERA and withdrew Market Authorization in Europe in September 2008. No efficacy, safety, or quality reason was associated with the premature halt of this study.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2006
First Posted
January 27, 2006
Study Start
March 6, 2006
Primary Completion
February 19, 2008
Study Completion
February 19, 2008
Last Updated
April 2, 2019
Results First Posted
August 26, 2009
Record last verified: 2019-04