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

Primary Purpose

Diabetes Mellitus Type 2

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inhaled Insulin (Exubera)
Standard of Care
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Type 2 diabetes melllitus

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diabetes mellitus type 2 Failing two or more oral anti-diabetic agents Exclusion Criteria: Asthma, COPD Smoking

Sites / Locations

  • Gain Medical Center
  • Misericordia Health Centre
  • Maritime Research Center
  • Office of Dr. Salim Sunderji
  • Orillia Soldier's Memorial Hospital
  • Douglas Tweel M.D. Professional Corporation
  • Laboratoire Sante Le Gaspesien Inc.
  • Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire
  • Rhodin Recherche Clinique
  • Q & T Research Outaouais Inc.
  • Hopital Charles LeMoyne
  • Hopital Laval
  • Centre Medical des Carrieres
  • CIC Mauricie Inc.
  • Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition
  • Groupe Hospitalier Sud/Service d'Endocrinologie
  • Private Practise
  • Service d'Endocrinologie-
  • Hopital LA Cavale Blanche, Service de Diabetologie
  • CHU Cote de Nacre, Service d'Endocrinologie
  • Private Practise
  • Office of Antoine Lemaire, MD
  • Centre Hospitalier Bretagne Sud
  • Hopital Lapeyronnie Sce des Maladies
  • Hopital Bichat, Service d'Endocrinology
  • Hopital Saint Michel
  • Hopital Robert Debre
  • C.H. Sud, Diabetologie
  • Centre Hospitalier Victor Provo
  • Hôpital Jeanne d'Arc - Dommartin les Toul
  • General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic
  • "Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic
  • "ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic
  • Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department
  • University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin
  • Hospital Infante D. Pedro
  • Hospitais da Universidade de Coimbra
  • Associação Protectora dos Diabéticos de Portugal
  • Serviço de Endocrinologia - Hospital de Egas Moniz
  • Hospital Geral de Santo António
  • Centro Hospitalar de Torres Vedras
  • Hospital Clinico Universitario de Santiago
  • Hospital de Conxo
  • Hospital Universitario Central de Asturias
  • Hospital de Bellvitge
  • Hospital Mutua de Terrassa
  • Clinica Universitaria de Navarra
  • Hospital General Universitario de Alicante
  • Hospital de La Santa Creu I Sant Pau
  • Hospital General Universitario Valle de Hebron
  • Hospital Universitario Puerta de Hierro
  • Hospital 12 de Octubre
  • Hospital de Mostoles
  • Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C
  • Hospital Montecelo
  • Hospital Universitario La Fe
  • Hospital Clinico Universitario de Valencia
  • Hospital Clinico Universitario Lozano Blesa
  • Sodersjukhuset
  • Karolinska US Huddinge
  • Ängelholms sjukhus
  • Hacettepe University Medical School Department of Endocrinology
  • Istanbul University Istanbul Medical School, Department of Endocrinology
  • Dokuz Eylul University Medical School, Department of Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Inhaled Insulin

Standard of Care

Arm Description

Inhaled insulin plus oral therapy

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

Outcomes

Primary Outcome Measures

Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
[(week 24 value - baseline value)/baseline value]*100%

Secondary Outcome Measures

Percentage of Participants Achieving Glycemic Control by Visit
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

Full Information

First Posted
January 26, 2006
Last Updated
April 1, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00282971
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminated as marketing of this product will be discontinued
Study Start Date
March 6, 2006 (Actual)
Primary Completion Date
February 19, 2008 (Actual)
Study Completion Date
February 19, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Type 2 diabetes melllitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Insulin
Arm Type
Experimental
Arm Description
Inhaled insulin plus oral therapy
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Intervention Type
Drug
Intervention Name(s)
Inhaled Insulin (Exubera)
Intervention Description
Addition of inhaled insulin to pre-existing oral diabetes therapy.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Primary Outcome Measure Information:
Title
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Description
[(week 24 value - baseline value)/baseline value]*100%
Time Frame
4, 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Glycemic Control by Visit
Description
2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%
Time Frame
4, 12 and 24 weeks
Title
Change From Baseline in FEV1 at Week 24 LOCF
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes mellitus type 2 Failing two or more oral anti-diabetic agents Exclusion Criteria: Asthma, COPD Smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Gain Medical Center
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
Misericordia Health Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1A2
Country
Canada
Facility Name
Maritime Research Center
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4X7
Country
Canada
Facility Name
Office of Dr. Salim Sunderji
City
London
State/Province
Ontario
ZIP/Postal Code
N6P 1A9
Country
Canada
Facility Name
Orillia Soldier's Memorial Hospital
City
Orillia
State/Province
Ontario
ZIP/Postal Code
L3V 2Z6
Country
Canada
Facility Name
Douglas Tweel M.D. Professional Corporation
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 1L2
Country
Canada
Facility Name
Laboratoire Sante Le Gaspesien Inc.
City
Bonaventure
State/Province
Quebec
ZIP/Postal Code
G0C 1E0
Country
Canada
Facility Name
Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Rhodin Recherche Clinique
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 1H8
Country
Canada
Facility Name
Q & T Research Outaouais Inc.
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 6S9
Country
Canada
Facility Name
Hopital Charles LeMoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V2H1
Country
Canada
Facility Name
Hopital Laval
City
Saint-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Centre Medical des Carrieres
City
St-Marc-des-Carrieres
State/Province
Quebec
ZIP/Postal Code
G0A 4B0
Country
Canada
Facility Name
CIC Mauricie Inc.
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition
City
Nantes
State/Province
Cedex 01
ZIP/Postal Code
F-44035
Country
France
Facility Name
Groupe Hospitalier Sud/Service d'Endocrinologie
City
Amiens cedex 1
ZIP/Postal Code
80094
Country
France
Facility Name
Private Practise
City
Armentieres
ZIP/Postal Code
59427
Country
France
Facility Name
Service d'Endocrinologie-
City
Bondy Cedex
ZIP/Postal Code
93143
Country
France
Facility Name
Hopital LA Cavale Blanche, Service de Diabetologie
City
Brest CEDEX
ZIP/Postal Code
29609
Country
France
Facility Name
CHU Cote de Nacre, Service d'Endocrinologie
City
Cean Cedex
ZIP/Postal Code
14033
Country
France
Facility Name
Private Practise
City
Chartres
ZIP/Postal Code
28000
Country
France
Facility Name
Office of Antoine Lemaire, MD
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Hospitalier Bretagne Sud
City
Lorient Cedex
ZIP/Postal Code
56322
Country
France
Facility Name
Hopital Lapeyronnie Sce des Maladies
City
Montpellier CEDEX 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Bichat, Service d'Endocrinology
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
Hopital Saint Michel
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Robert Debre
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
C.H. Sud, Diabetologie
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Centre Hospitalier Victor Provo
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Hôpital Jeanne d'Arc - Dommartin les Toul
City
Toul Cedex
ZIP/Postal Code
54201
Country
France
Facility Name
General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
"Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic
City
Athens
ZIP/Postal Code
151 23
Country
Greece
Facility Name
"ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic
City
Haidari
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department
City
Pireaus
ZIP/Postal Code
18454
Country
Greece
Facility Name
University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Hospital Infante D. Pedro
City
Aveiro
ZIP/Postal Code
3814-096
Country
Portugal
Facility Name
Hospitais da Universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Associação Protectora dos Diabéticos de Portugal
City
Lisboa
ZIP/Postal Code
1250-203
Country
Portugal
Facility Name
Serviço de Endocrinologia - Hospital de Egas Moniz
City
Lisboa
ZIP/Postal Code
1300
Country
Portugal
Facility Name
Hospital Geral de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Centro Hospitalar de Torres Vedras
City
Torres Vedras
ZIP/Postal Code
2560-324
Country
Portugal
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital de Conxo
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital General Universitario Valle de Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital de Mostoles
City
Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Hospital Montecelo
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Sodersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Karolinska US Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Ängelholms sjukhus
City
Ängelholm
ZIP/Postal Code
262 81
Country
Sweden
Facility Name
Hacettepe University Medical School Department of Endocrinology
City
Anakara
Country
Turkey
Facility Name
Istanbul University Istanbul Medical School, Department of Endocrinology
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Dokuz Eylul University Medical School, Department of Endocrinology
City
Izmir
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171063&StudyName=A%20Clinical%20Trial%20Assessing%20The%20Impact%20Of%20Inhaled%20Insulin%20On%20Glucose%20Control%20In%20Patients%20With%20Type%202%20Diabetes%20Mellitus
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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