A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control

NCT ID: NCT00134147

Last Updated: 2008-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-05-31

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Inhaled Insulin

Intervention Type DRUG

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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Sanofi

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

La Jolla, California, United States

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San Diego, California, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Columbus, Georgia, United States

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Overland Park, Kansas, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Medford, Oregon, United States

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Hershey, Pennsylvania, United States

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Spartanburg, South Carolina, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Red Deer, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Corunna, Ontario, Canada

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Oakville, Ontario, Canada

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Smith Falls, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Béthune, , France

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Bourg-en-Bresse, , France

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Bron, , France

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Corbeil-Essonnes, , France

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La Rochelle, , France

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Montpellier, , France

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Nantes, , France

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Roubaix, , France

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Tours, , France

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Altenburg, , Germany

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Aschaffenburg, , Germany

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Bad Mergentheim, , Germany

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Bad Oeynhausen/ Volmerdingen, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Delmenhorst, , Germany

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Dresden, , Germany

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Ebersdorf, , Germany

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Eisenach, , Germany

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Falkensee, , Germany

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Furth im Wald, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Haßloch, , Germany

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Künzing, , Germany

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Leipzig, , Germany

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Meissen, , Germany

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Mittweida, , Germany

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Münster, , Germany

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Münster, , Germany

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Offenbach, , Germany

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Offenburg, , Germany

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Oschatz, , Germany

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Pirna, , Germany

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Riedlhuette, , Germany

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Riesa, , Germany

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Rossach, , Germany

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Schwabenheim, , Germany

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St.Ingbert, , Germany

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Surwold, , Germany

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Wangen, , Germany

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Wangen / Allgaeu, , Germany

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Witten, , Germany

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Bari, , Italy

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Catania, , Italy

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Florence, , Italy

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Genova, , Italy

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Milan, , Italy

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Napoli, , Italy

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Padua, , Italy

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Palermo, , Italy

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Pescara, , Italy

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Pisa, , Italy

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Roma, , Italy

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Torino, , Italy

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Udine, , Italy

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Verona, , Italy

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Badalona, Barcelona, Spain

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Barcelona, BARCELONA, Spain

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Barcelona, BARCELONA, Spain

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Barcelona, BARCELONA, Spain

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Cadiz, CADIZ, Spain

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Girona, GERONA, Spain

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Granada, GRANADA, Spain

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Las Palmas, LAS Palmas de GRAN Canaria, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Seville, SEVILLA, Spain

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Valencia, Valencia, Spain

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Barakaldo, VIZCAYA, Spain

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Bilbao, VIZCAYA, Spain

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Ayr, Ayrshire, United Kingdom

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Thornhill, Cardiff, United Kingdom

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Penzance, CORNWALL, United Kingdom

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St Austell, Cornwall, United Kingdom

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Truro, Cornwall, United Kingdom

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Plymouth, DEVON, United Kingdom

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Letchworth Garden City, Hertfordshire, United Kingdom

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Sidcup, Kent, United Kingdom

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Whitstable, Kent, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Colney, Norwich, United Kingdom

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Headington, Oxford, United Kingdom

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Penarth, South Glamorgan, United Kingdom

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Dundee, Tayside, United Kingdom

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Haywards Heath, West Sussex, United Kingdom

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Birmingham, , United Kingdom

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Bolton, , United Kingdom

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Canterbury, , United Kingdom

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Liverpool, , United Kingdom

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Salford, , United Kingdom

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York, , United Kingdom

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Countries

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United States Canada France Germany Italy Spain United Kingdom

References

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Freemantle N, Strack TR; Real World Trialists. Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial. Trials. 2006 Aug 10;7:25. doi: 10.1186/1745-6215-7-25.

Reference Type DERIVED
PMID: 16901335 (View on PubMed)

Related Links

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Other Identifiers

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A2171018

Identifier Type: -

Identifier Source: org_study_id