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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00282971
First received: January 26, 2006
Last updated: September 11, 2009
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus Type 2
Other: Standard of Care
Drug: Inhaled Insulin (Exubera)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Six Month, Open-Label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-Diabetic Agents.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: 4, 12 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants Achieving Glycemic Control by Visit [ Time Frame: 4, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in FEV1 at Week 24 LOCF [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 354
Study Start Date: March 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Insulin
Inhaled insulin plus oral therapy
Drug: Inhaled Insulin (Exubera)
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
Other: Standard of Care
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Detailed Description:

The study was terminated on Nov. 9, 2007. This study pursued scientific questions that were complementary to the wealth of data already available for Exubera. Pfizer decided to cancel new trials because of the decision to withdraw Exubera due to lack of market performance and not for safety reasons.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Asthma, COPD
  • Smoking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282971

  Hide Study Locations
Locations
Canada, British Columbia
Pfizer Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3C 1A2
Canada, New Brunswick
Pfizer Investigational Site
Bathurst, New Brunswick, Canada, E2A 4X7
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6P 1A9
Pfizer Investigational Site
Orillia, Ontario, Canada, L3V 2Z6
Canada, Prince Edward Island
Pfizer Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 1L2
Canada, Quebec
Pfizer Investigational Site
Bonaventure, Quebec, Canada, G0C 1E0
Pfizer Investigational Site
Chicoutimi, Quebec, Canada, G7H 5H6
Pfizer Investigational Site
Drummondville, Quebec, Canada, J2B 1H8
Pfizer Investigational Site
Gatineau, Quebec, Canada, J8Y 6S9
Pfizer Investigational Site
Greenfield Park, Quebec, Canada, J4V2H1
Pfizer Investigational Site
Saint-Foy, Quebec, Canada, G1V 4G5
Pfizer Investigational Site
St-Marc-des-Carrières, Quebec, Canada, G0A 4B0
Pfizer Investigational Site
Trois-Rivières, Quebec, Canada, G8T 7A1
France
Pfizer Investigational Site
Nantes, Cedex 01, France, F-44035
Pfizer Investigational Site
Amiens cedex 1, France, 80094
Pfizer Investigational Site
Armentieres, France, 59427
Pfizer Investigational Site
Bondy Cedex, France, 93143
Pfizer Investigational Site
Brest CEDEX, France, 29609
Pfizer Investigational Site
Caen, France, 14033
Pfizer Investigational Site
Chartres, France, 28000
Pfizer Investigational Site
Lille, France, 59000
Pfizer Investigational Site
Lorient, France, 56322
Pfizer Investigational Site
Montpellier CEDEX 5, France, 34295
Pfizer Investigational Site
Paris, France, 75015
Pfizer Investigational Site
Paris Cedex 18, France, 75877
Pfizer Investigational Site
Reims, France, 51100
Pfizer Investigational Site
Rennes, France, 35056
Pfizer Investigational Site
Roubaix, France, 59100
Pfizer Investigational Site
Toul Cedex, France, 54201
Greece
Pfizer Investigational Site
Athens, Greece, 11527
Pfizer Investigational Site
Athens, Greece, 151 23
Pfizer Investigational Site
Haidari, Greece, 124 62
Pfizer Investigational Site
Piraeus, Greece, 18454
Pfizer Investigational Site
Thessaloniki, Greece, 546 36
Portugal
Pfizer Investigational Site
Aveiro, Portugal, 3814-096
Pfizer Investigational Site
Coimbra, Portugal, 3000-075
Pfizer Investigational Site
Lisboa, Portugal, 1300
Pfizer Investigational Site
Lisboa, Portugal, 1250-203
Pfizer Investigational Site
Porto, Portugal, 4099-001
Pfizer Investigational Site
Torres Vedras, Portugal, 2560-324
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 15706
Pfizer Investigational Site
Oviedo, Asturias, Spain, 33006
Pfizer Investigational Site
Hospitalet de Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site
Terrassa, Barcelona, Spain, 08221
Pfizer Investigational Site
Pamplona, Navarra, Spain, 31008
Pfizer Investigational Site
Alicante, Spain, 03010
Pfizer Investigational Site
Barcelona, Spain, 08025
Pfizer Investigational Site
Barcelona, Spain, 08035
Pfizer Investigational Site
Madrid, Spain, 28935
Pfizer Investigational Site
Madrid, Spain, 28041
Pfizer Investigational Site
Madrid, Spain, 28035
Pfizer Investigational Site
Malaga, Spain, 29009
Pfizer Investigational Site
Pontevedra, Spain, 36071
Pfizer Investigational Site
Valencia, Spain, 46010
Pfizer Investigational Site
Valencia, Spain, 46009
Pfizer Investigational Site
Zaragoza, Spain, 50009
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 141 86
Pfizer Investigational Site
Stockholm, Sweden, 118 83
Pfizer Investigational Site
Ängelholm, Sweden, 262 81
Turkey
Pfizer Investigational Site
Ankara, Turkey
Pfizer Investigational Site
Istanbul, Turkey, 34390
Pfizer Investigational Site
Izmir, Turkey, 35340
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00282971     History of Changes
Other Study ID Numbers: A2171063, EXACTA
Study First Received: January 26, 2006
Results First Received: February 11, 2009
Last Updated: September 11, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Type 2 diabetes melllitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014