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

NCT ID: NCT00282971

Last Updated: 2019-04-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-06

Study Completion Date

2008-02-19

Brief Summary

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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

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inhaled Insulin

Inhaled insulin plus oral therapy

Group Type EXPERIMENTAL

Inhaled Insulin (Exubera)

Intervention Type DRUG

Addition of inhaled insulin to pre-existing oral diabetes therapy.

Standard of Care

Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Group Type OTHER

Standard of Care

Intervention Type OTHER

Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Interventions

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Inhaled Insulin (Exubera)

Addition of inhaled insulin to pre-existing oral diabetes therapy.

Intervention Type DRUG

Standard of Care

Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Asthma, COPD
* Smoking
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Ängelholms sjukhus

Ängelholm, , Sweden

Site Status

Sodersjukhuset

Stockholm, , Sweden

Site Status

Karolinska US Huddinge

Stockholm, , Sweden

Site Status

Gain Medical Center

Coquitlam, British Columbia, Canada

Site Status

Misericordia Health Centre

Winnipeg, Manitoba, Canada

Site Status

Maritime Research Center

Bathurst, New Brunswick, Canada

Site Status

Office of Dr. Salim Sunderji

London, Ontario, Canada

Site Status

Orillia Soldier's Memorial Hospital

Orillia, Ontario, Canada

Site Status

Douglas Tweel M.D. Professional Corporation

Charlottetown, Prince Edward Island, Canada

Site Status

Laboratoire Sante Le Gaspesien Inc.

Bonaventure, Quebec, Canada

Site Status

Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire

Chicoutimi, Quebec, Canada

Site Status

Rhodin Recherche Clinique

Drummondville, Quebec, Canada

Site Status

Q & T Research Outaouais Inc.

Gatineau, Quebec, Canada

Site Status

Hopital Charles LeMoyne

Greenfield Park, Quebec, Canada

Site Status

Hopital Laval

Saint-Foy, Quebec, Canada

Site Status

Centre Medical des Carrieres

Saint-Marc-des-Carrieres, Quebec, Canada

Site Status

CIC Mauricie Inc.

Trois-Rivières, Quebec, Canada

Site Status

Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition

Nantes, Cedex 01, France

Site Status

Groupe Hospitalier Sud/Service d'Endocrinologie

Amiens, , France

Site Status

Private Practise

Armentières, , France

Site Status

Service d'Endocrinologie-

Bondy, , France

Site Status

Hopital LA Cavale Blanche, Service de Diabetologie

Brest, , France

Site Status

CHU Cote de Nacre, Service d'Endocrinologie

Cean Cedex, , France

Site Status

Private Practise

Chartres, , France

Site Status

Office of Antoine Lemaire, MD

Lille, , France

Site Status

Centre Hospitalier Bretagne Sud

Lorient, , France

Site Status

Hopital Lapeyronnie Sce des Maladies

Montpellier, , France

Site Status

Hopital Saint Michel

Paris, , France

Site Status

Hopital Bichat, Service d'Endocrinology

Paris, , France

Site Status

Hopital Robert Debre

Reims, , France

Site Status

C.H. Sud, Diabetologie

Rennes, , France

Site Status

Centre Hospitalier Victor Provo

Roubaix, , France

Site Status

Hôpital Jeanne d'Arc - Dommartin les Toul

Toul, , France

Site Status

General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic

Athens, , Greece

Site Status

"Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic

Athens, , Greece

Site Status

"ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic

Haidari, , Greece

Site Status

Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department

Pireaus, , Greece

Site Status

University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin

Thessaloniki, , Greece

Site Status

Hospital Infante D. Pedro

Aveiro, , Portugal

Site Status

Hospitais da Universidade de Coimbra

Coimbra, , Portugal

Site Status

Associação Protectora dos Diabéticos de Portugal

Lisbon, , Portugal

Site Status

Serviço de Endocrinologia - Hospital de Egas Moniz

Lisbon, , Portugal

Site Status

Hospital Geral de Santo António

Porto, , Portugal

Site Status

Centro Hospitalar de Torres Vedras

Torres Vedras, , Portugal

Site Status

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status

Hospital de Conxo

Santiago de Compostela, A Coruña, Spain

Site Status

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Mutua de Terrassa

Terrassa, Barcelona, Spain

Site Status

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

Hospital de La Santa Creu I Sant Pau

Barcelona, , Spain

Site Status

Hospital General Universitario Valle de Hebron

Barcelona, , Spain

Site Status

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Site Status

Hospital 12 de Octubre

Madrid, , Spain

Site Status

Hospital de Mostoles

Madrid, , Spain

Site Status

Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C

Málaga, , Spain

Site Status

Hospital Montecelo

Pontevedra, , Spain

Site Status

Hospital Universitario La Fe

Valencia, , Spain

Site Status

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

Site Status

Hacettepe University Medical School Department of Endocrinology

Ankara, , Turkey (Türkiye)

Site Status

Istanbul University Istanbul Medical School, Department of Endocrinology

Istanbul, , Turkey (Türkiye)

Site Status

Dokuz Eylul University Medical School, Department of Endocrinology

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Canada France Greece Portugal Spain Sweden Turkey (Türkiye)

Related Links

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Other Identifiers

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EXACTA

Identifier Type: OTHER

Identifier Source: secondary_id

2005-003504-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A2171063

Identifier Type: -

Identifier Source: org_study_id

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