A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Sanofi
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00134147
First received: August 22, 2005
Last updated: April 16, 2008
Last verified: April 2008
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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 |
Drug: Inhaled Insulin |
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 One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Glycosylated hemoglobin
Secondary Outcome Measures:
- Percent of patients achieving good control of fasting glucose and lipids
- Rate of hypoglycemia
- Changes in body weight
- Patient satisfaction
- Safety based on adverse events reported and laboratory tests
| Estimated Enrollment: | 1100 |
| Study Start Date: | April 2005 |
| Study Completion Date: | May 2007 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134147
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| United States, California | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92037 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92128 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32208 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32209 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Columbus, Georgia, United States, 31904 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66211 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21230 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Charlotte, North Carolina, United States, 28207 | |
| Pfizer Investigational Site | |
| Charlotte, North Carolina, United States, 28212 | |
| Pfizer Investigational Site | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Medford, Oregon, United States, 97504-8491 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78237 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2L 1K8 | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T5J 3N4 | |
| Pfizer Investigational Site | |
| Red Deer, Alberta, Canada, T4N 6V7 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Corunna, Ontario, Canada, N0N 1G0 | |
| Pfizer Investigational Site | |
| Oakville, Ontario, Canada, L6H 3P1 | |
| Pfizer Investigational Site | |
| Smith Falls, Ontario, Canada, K7A 4W8 | |
| Canada, Prince Edward Island | |
| Pfizer Investigational Site | |
| Charlottetown, Prince Edward Island, Canada, C1A 5Y9 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Laval, Quebec, Canada, H7T 2P5 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| France | |
| Pfizer Investigational Site | |
| Bethune CEDEX, France, 62408 | |
| Pfizer Investigational Site | |
| Bourg En Bresse, France, 01012 | |
| Pfizer Investigational Site | |
| Bron, France, 69500 | |
| Pfizer Investigational Site | |
| Corbeil Essonnes Cedex, France, 91106 | |
| Pfizer Investigational Site | |
| La Rochelle Cedex, France, 17019 | |
| Pfizer Investigational Site | |
| Montpellier CEDEX, France, F-34295 | |
| Pfizer Investigational Site | |
| Nantes, France, 44000 | |
| Pfizer Investigational Site | |
| Roubaix, France, 59100 | |
| Pfizer Investigational Site | |
| TOURS cedex 7, France, 37044 | |
| Germany | |
| Pfizer Investigational Site | |
| Altenburg, Germany, 04600 | |
| Pfizer Investigational Site | |
| Aschaffenburg, Germany, 63739 | |
| Pfizer Investigational Site | |
| Bad Oeynhausen/ Volmerdingen, Germany, 32549 | |
| Pfizer Investigational Site | |
| Bad-Mergentheim, Germany, 97980 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 12687 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 14057 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10115 | |
| Pfizer Investigational Site | |
| Delmenhorst, Germany, 27753 | |
| Pfizer Investigational Site | |
| Dresden, Germany, 01219 | |
| Pfizer Investigational Site | |
| Ebersdorf, Germany, 96237 | |
| Pfizer Investigational Site | |
| Eisenach, Germany, 99817 | |
| Pfizer Investigational Site | |
| Falkensee, Germany, 14612 | |
| Pfizer Investigational Site | |
| Furth im Wald, Germany, 93437 | |
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| Hamburg, Germany, 21073 | |
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| Hamburg, Germany, 22391 | |
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| Hassloch, Germany, 67454 | |
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| Kuenzing, Germany, 94550 | |
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| Leipzig, Germany, 04103 | |
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| Meissen, Germany, 01662 | |
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| Mittweida, Germany, 09648 | |
| Pfizer Investigational Site | |
| Muenster, Germany, 48153 | |
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| Muenster, Germany, 48145 | |
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| Offenbach, Germany, 63065 | |
| Pfizer Investigational Site | |
| Offenburg, Germany, 77654 | |
| Pfizer Investigational Site | |
| Oschatz, Germany, 04758 | |
| Pfizer Investigational Site | |
| Pirna, Germany, 01796 | |
| Pfizer Investigational Site | |
| Riedlhuette, Germany, 94566 | |
| Pfizer Investigational Site | |
| Riesa, Germany, 01587 | |
| Pfizer Investigational Site | |
| Rossach, Germany, 96269 | |
| Pfizer Investigational Site | |
| Schwabenheim, Germany, 55270 | |
| Pfizer Investigational Site | |
| St.Ingbert, Germany, 66386 | |
| Pfizer Investigational Site | |
| Surwold, Germany, 26903 | |
| Pfizer Investigational Site | |
| Wangen, Germany, 88239 | |
| Pfizer Investigational Site | |
| Wangen / Allgaeu, Germany, 88239 | |
| Pfizer Investigational Site | |
| Witten, Germany, 58455 | |
| Italy | |
| Pfizer Investigational Site | |
| Bari, Italy, 70124 | |
| Pfizer Investigational Site | |
| Catania, Italy, 95122 | |
| Pfizer Investigational Site | |
| Firenze, Italy, 50134 | |
| Pfizer Investigational Site | |
| Genova, Italy, 16132 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20132 | |
| Pfizer Investigational Site | |
| Napoli, Italy, 80131 | |
| Pfizer Investigational Site | |
| Padova, Italy, 35128 | |
| Pfizer Investigational Site | |
| Palermo, Italy, 90127 | |
| Pfizer Investigational Site | |
| Pescara, Italy, 65100 | |
| Pfizer Investigational Site | |
| Pisa, Italy, 56124 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00133 | |
| Pfizer Investigational Site | |
| Torino, Italy, 10126 | |
| Pfizer Investigational Site | |
| Udine, Italy, 33100 | |
| Pfizer Investigational Site | |
| Verona, Italy, 37126 | |
| Spain | |
| Pfizer Investigational Site | |
| Badalona, Barcelona, Spain, 08916 | |
| Pfizer Investigational Site | |
| Las Palmas, Las Palmas de Gran Canaria, Spain, 35010 | |
| Pfizer Investigational Site | |
| Baracaldo, Vizcaya, Spain, 48903 | |
| Pfizer Investigational Site | |
| Bilbao, Vizcaya, Spain, 48013 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08036 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08017 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08003 | |
| Pfizer Investigational Site | |
| Cadiz, Spain, 11009 | |
| Pfizer Investigational Site | |
| Gerona, Spain, 17007 | |
| Pfizer Investigational Site | |
| Granada, Spain, 18012 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28034 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28040 | |
| Pfizer Investigational Site | |
| Sevilla, Spain, 41014 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46017 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Ayr, Ayrshire, United Kingdom, KA7 1BJ | |
| Pfizer Investigational Site | |
| Thornhill, Cardiff, United Kingdom, CF14 9BB | |
| Pfizer Investigational Site | |
| Penzance, Cornwall, United Kingdom, TR18 4JH | |
| Pfizer Investigational Site | |
| St. Austell, Cornwall, United Kingdom, PL26 7RL | |
| Pfizer Investigational Site | |
| Truro, Cornwall, United Kingdom, TR1 3LJ | |
| Pfizer Investigational Site | |
| Plymouth, Devon, United Kingdom, PL6 8BX | |
| Pfizer Investigational Site | |
| Letchworth, Hertfordshire, United Kingdom, SG6 4UB | |
| Pfizer Investigational Site | |
| Sidcup, Kent, United Kingdom, DA14 6LT | |
| Pfizer Investigational Site | |
| Whitstable, Kent, United Kingdom, CT5 3QU | |
| Pfizer Investigational Site | |
| Blackpool, Lancashire, United Kingdom, FY3 7EN | |
| Pfizer Investigational Site | |
| Colney, Norwich, United Kingdom, NR4 7UY | |
| Pfizer Investigational Site | |
| Headington, Oxford, United Kingdom, OX3 7LJ | |
| Pfizer Investigational Site | |
| Penarth, South Glamorgan, United Kingdom, CF64 2XX | |
| Pfizer Investigational Site | |
| Dundee, Tayside, United Kingdom, DD1 9SY | |
| Pfizer Investigational Site | |
| Haywards Heath, West Sussex, United Kingdom, RH16 4EX | |
| Pfizer Investigational Site | |
| Birmingham, United Kingdom, B9 5SS | |
| Pfizer Investigational Site | |
| Bolton, United Kingdom, BL3 6TL | |
| Pfizer Investigational Site | |
| Canterbury, United Kingdom, CT1 3HX | |
| Pfizer Investigational Site | |
| Liverpool, United Kingdom, L7 8XP | |
| Pfizer Investigational Site | |
| Salford, United Kingdom, M6 8HD | |
| Pfizer Investigational Site | |
| York, United Kingdom, YO31 8HE | |
Sponsors and Collaborators
Pfizer
Sanofi
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00134147 History of Changes |
| Other Study ID Numbers: | A2171018 |
| Study First Received: | August 22, 2005 |
| Last Updated: | April 16, 2008 |
| Health Authority: | United States: Food and Drug Administration |
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 May 23, 2013