A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Drug: Inhaled Insulin (Exubera)Other: Standard of Care
- Registration Number
- NCT00282971
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 354
- Diabetes mellitus type 2
- Failing two or more oral anti-diabetic agents
- Asthma, COPD
- Smoking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled Insulin Inhaled Insulin (Exubera) Inhaled insulin plus oral therapy Standard of Care Standard of Care Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
- Primary Outcome Measures
Name Time Method Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 4, 12 and 24 weeks \[(week 24 value - baseline value)/baseline value\]\*100%
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Glycemic Control by Visit 4, 12 and 24 weeks 2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%
Change From Baseline in FEV1 at Week 24 LOCF 24 weeks
Trial Locations
- Locations (63)
Gain Medical Center
🇨🇦Coquitlam, British Columbia, Canada
Orillia Soldier's Memorial Hospital
🇨🇦Orillia, Ontario, Canada
Maritime Research Center
🇨🇦Bathurst, New Brunswick, Canada
Office of Dr. Salim Sunderji
🇨🇦London, Ontario, Canada
Laboratoire Sante Le Gaspesien Inc.
🇨🇦Bonaventure, Quebec, Canada
Douglas Tweel M.D. Professional Corporation
🇨🇦Charlottetown, Prince Edward Island, Canada
Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire
🇨🇦Chicoutimi, Quebec, Canada
Rhodin Recherche Clinique
🇨🇦Drummondville, Quebec, Canada
Q & T Research Outaouais Inc.
🇨🇦Gatineau, Quebec, Canada
Hopital Charles LeMoyne
🇨🇦Greenfield Park, Quebec, Canada
Centre Medical des Carrieres
🇨🇦St-Marc-des-Carrieres, Quebec, Canada
CIC Mauricie Inc.
🇨🇦Trois-Rivières, Quebec, Canada
Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition
🇫🇷Nantes, Cedex 01, France
Service d'Endocrinologie-
🇫🇷Bondy Cedex, France
Groupe Hospitalier Sud/Service d'Endocrinologie
🇫🇷Amiens cedex 1, France
Hopital LA Cavale Blanche, Service de Diabetologie
🇫🇷Brest CEDEX, France
Centre Hospitalier Bretagne Sud
🇫🇷Lorient Cedex, France
Private Practise
🇫🇷Chartres, France
CHU Cote de Nacre, Service d'Endocrinologie
🇫🇷Cean Cedex, France
Office of Antoine Lemaire, MD
🇫🇷Lille, France
Hopital Lapeyronnie Sce des Maladies
🇫🇷Montpellier CEDEX 5, France
Hopital Bichat, Service d'Endocrinology
🇫🇷Paris Cedex 18, France
Hopital Saint Michel
🇫🇷Paris, France
Hopital Robert Debre
🇫🇷Reims, France
C.H. Sud, Diabetologie
🇫🇷Rennes, France
Centre Hospitalier Victor Provo
🇫🇷Roubaix, France
Hôpital Jeanne d'Arc - Dommartin les Toul
🇫🇷Toul Cedex, France
General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic
🇬🇷Athens, Greece
"Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic
🇬🇷Athens, Greece
"ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic
🇬🇷Haidari, Greece
Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department
🇬🇷Pireaus, Greece
University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin
🇬🇷Thessaloniki, Greece
Hospital Infante D. Pedro
🇵🇹Aveiro, Portugal
Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Associação Protectora dos Diabéticos de Portugal
🇵🇹Lisboa, Portugal
Serviço de Endocrinologia - Hospital de Egas Moniz
🇵🇹Lisboa, Portugal
Centro Hospitalar de Torres Vedras
🇵🇹Torres Vedras, Portugal
Hospital Geral de Santo António
🇵🇹Porto, Portugal
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital de Conxo
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital de Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Mutua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Clinica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital General Universitario Valle de Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Hospital de Mostoles
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C
🇪🇸Malaga, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Montecelo
🇪🇸Pontevedra, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Sodersjukhuset
🇸🇪Stockholm, Sweden
Karolinska US Huddinge
🇸🇪Stockholm, Sweden
Ängelholms sjukhus
🇸🇪Ängelholm, Sweden
Dokuz Eylul University Medical School, Department of Endocrinology
🇹🇷Izmir, Turkey
Istanbul University Istanbul Medical School, Department of Endocrinology
🇹🇷Istanbul, Turkey
Hacettepe University Medical School Department of Endocrinology
🇹🇷Anakara, Turkey
Hopital Laval
🇨🇦Saint-Foy, Quebec, Canada
Misericordia Health Centre
🇨🇦Winnipeg, Manitoba, Canada