Clinical trial NCT00282971: A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Keywords: Type 2 diabetes melllitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-27
Enrollment: 354
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Asthma, COPD
* Smoking

Primary outcomes:
measure: Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
timeFrame: 4, 12 and 24 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving Glycemic Control by Visit
timeFrame: 4, 12 and 24 weeks
measure: Change From Baseline in FEV1 at Week 24 LOCF
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Coquitlam
country: Canada
facility: Gain Medical Center
state: British Columbia
city: Winnipeg
country: Canada
facility: Misericordia Health Centre
state: Manitoba
city: Bathurst
country: Canada
facility: Maritime Research Center
state: New Brunswick
city: London
country: Canada
facility: Office of Dr. Salim Sunderji
state: Ontario
city: Orillia
country: Canada
facility: Orillia Soldier's Memorial Hospital
state: Ontario
city: Charlottetown
country: Canada
facility: Douglas Tweel M.D. Professional Corporation
state: Prince Edward Island
city: Bonaventure
country: Canada
facility: Laboratoire Sante Le Gaspesien Inc.
state: Quebec
city: Chicoutimi
country: Canada
facility: Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire
state: Quebec
city: Drummondville
country: Canada
facility: Rhodin Recherche Clinique
state: Quebec
city: Gatineau
country: Canada
facility: Q & T Research Outaouais Inc.
state: Quebec
city: Greenfield Park
country: Canada
facility: Hopital Charles LeMoyne
state: Quebec
city: Saint-Foy
country: Canada
facility: Hopital Laval
state: Quebec
city: St-Marc-des-Carrieres
country: Canada
facility: Centre Medical des Carrieres
state: Quebec
city: Trois-Rivières
country: Canada
facility: CIC Mauricie Inc.
state: Quebec
city: Nantes
country: France
facility: Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition
state: Cedex 01
city: Amiens cedex 1
country: France
facility: Groupe Hospitalier Sud/Service d'Endocrinologie
city: Armentieres
country: France
facility: Private Practise
city: Bondy Cedex
country: France
facility: Service d'Endocrinologie-
city: Brest CEDEX
country: France
facility: Hopital LA Cavale Blanche, Service de Diabetologie
city: Cean Cedex
country: France
facility: CHU Cote de Nacre, Service d'Endocrinologie
city: Chartres
country: France
facility: Private Practise
city: Lille
country: France
facility: Office of Antoine Lemaire, MD
city: Lorient Cedex
country: France
facility: Centre Hospitalier Bretagne Sud
city: Montpellier CEDEX 5
country: France
facility: Hopital Lapeyronnie Sce des Maladies
city: Paris Cedex 18
country: France
facility: Hopital Bichat, Service d'Endocrinology
city: Paris
country: France
facility: Hopital Saint Michel
city: Reims
country: France
facility: Hopital Robert Debre
city: Rennes
country: France
facility: C.H. Sud, Diabetologie
city: Roubaix
country: France
facility: Centre Hospitalier Victor Provo
city: Toul Cedex
country: France
facility: Hôpital Jeanne d'Arc - Dommartin les Toul
city: Athens
country: Greece
facility: General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic
city: Athens
country: Greece
facility: "Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic
city: Haidari
country: Greece
facility: "ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic
city: Pireaus
country: Greece
facility: Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department
city: Thessaloniki
country: Greece
facility: University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin
city: Aveiro
country: Portugal
facility: Hospital Infante D. Pedro
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: Associação Protectora dos Diabéticos de Portugal
city: Lisboa
country: Portugal
facility: Serviço de Endocrinologia - Hospital de Egas Moniz
city: Porto
country: Portugal
facility: Hospital Geral de Santo António
city: Torres Vedras
country: Portugal
facility: Centro Hospitalar de Torres Vedras
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: A Coruña
city: Santiago de Compostela
country: Spain
facility: Hospital de Conxo
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital General Universitario Valle de Hebron
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital de Mostoles
city: Malaga
country: Spain
facility: Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C
city: Pontevedra
country: Spain
facility: Hospital Montecelo
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Stockholm
country: Sweden
facility: Sodersjukhuset
city: Stockholm
country: Sweden
facility: Karolinska US Huddinge
city: Ängelholm
country: Sweden
facility: Ängelholms sjukhus
city: Anakara
country: Turkey
facility: Hacettepe University Medical School Department of Endocrinology
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical School, Department of Endocrinology
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical School, Department of Endocrinology
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: