A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00134147
Collaborator
Sanofi (Industry)
1,100
121
25
9.1
0.4
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date
:
Apr 1, 2005
Actual Study Completion Date
:
May 1, 2007
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
35 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diabetes mellitus Type 2
-
Failing two or more oral anti-diabetic agents
Exclusion Criteria:
-
Asthma, COPD
-
Smoking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | La Jolla | California | United States | 92037 |
| 2 | Pfizer Investigational Site | San Diego | California | United States | 92128 |
| 3 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20010 |
| 4 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32208 |
| 5 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32209 |
| 6 | Pfizer Investigational Site | Miami | Florida | United States | 33136 |
| 7 | Pfizer Investigational Site | Columbus | Georgia | United States | 31904 |
| 8 | Pfizer Investigational Site | Overland Park | Kansas | United States | 66211 |
| 9 | Pfizer Investigational Site | New Orleans | Louisiana | United States | 70121 |
| 10 | Pfizer Investigational Site | Baltimore | Maryland | United States | 21230 |
| 11 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28207 |
| 12 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28212 |
| 13 | Pfizer Investigational Site | Raleigh | North Carolina | United States | 27609 |
| 14 | Pfizer Investigational Site | Medford | Oregon | United States | 97504-8491 |
| 15 | Pfizer Investigational Site | Hershey | Pennsylvania | United States | 17033-0850 |
| 16 | Pfizer Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 17 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229 |
| 18 | Pfizer Investigational Site | San Antonio | Texas | United States | 78237 |
| 19 | Pfizer Investigational Site | Calgary | Alberta | Canada | T2L 1K8 |
| 20 | Pfizer Investigational Site | Edmonton | Alberta | Canada | T5J 3N4 |
| 21 | Pfizer Investigational Site | Red Deer | Alberta | Canada | T4N 6V7 |
| 22 | Pfizer Investigational Site | Winnipeg | Manitoba | Canada | R3E 3P4 |
| 23 | Pfizer Investigational Site | Corunna | Ontario | Canada | N0N 1G0 |
| 24 | Pfizer Investigational Site | Oakville | Ontario | Canada | L6H 3P1 |
| 25 | Pfizer Investigational Site | Smith Falls | Ontario | Canada | K7A 4W8 |
| 26 | Pfizer Investigational Site | Charlottetown | Prince Edward Island | Canada | C1A 5Y9 |
| 27 | Pfizer Investigational Site | Laval | Quebec | Canada | H7T 2P5 |
| 28 | Pfizer Investigational Site | Montreal | Quebec | Canada | H3A 1A1 |
| 29 | Pfizer Investigational Site | Bethune CEDEX | France | 62408 | |
| 30 | Pfizer Investigational Site | Bourg En Bresse | France | 01012 | |
| 31 | Pfizer Investigational Site | Bron | France | 69500 | |
| 32 | Pfizer Investigational Site | Corbeil Essonnes Cedex | France | 91106 | |
| 33 | Pfizer Investigational Site | La Rochelle Cedex | France | 17019 | |
| 34 | Pfizer Investigational Site | Montpellier CEDEX | France | F-34295 | |
| 35 | Pfizer Investigational Site | Nantes | France | 44000 | |
| 36 | Pfizer Investigational Site | Roubaix | France | 59100 | |
| 37 | Pfizer Investigational Site | TOURS cedex 7 | France | 37044 | |
| 38 | Pfizer Investigational Site | Altenburg | Germany | 04600 | |
| 39 | Pfizer Investigational Site | Aschaffenburg | Germany | 63739 | |
| 40 | Pfizer Investigational Site | Bad Oeynhausen/ Volmerdingen | Germany | 32549 | |
| 41 | Pfizer Investigational Site | Bad-Mergentheim | Germany | 97980 | |
| 42 | Pfizer Investigational Site | Berlin | Germany | 10115 | |
| 43 | Pfizer Investigational Site | Berlin | Germany | 12687 | |
| 44 | Pfizer Investigational Site | Berlin | Germany | 14057 | |
| 45 | Pfizer Investigational Site | Delmenhorst | Germany | 27753 | |
| 46 | Pfizer Investigational Site | Dresden | Germany | 01219 | |
| 47 | Pfizer Investigational Site | Ebersdorf | Germany | 96237 | |
| 48 | Pfizer Investigational Site | Eisenach | Germany | 99817 | |
| 49 | Pfizer Investigational Site | Falkensee | Germany | 14612 | |
| 50 | Pfizer Investigational Site | Furth im Wald | Germany | 93437 | |
| 51 | Pfizer Investigational Site | Hamburg | Germany | 21073 | |
| 52 | Pfizer Investigational Site | Hamburg | Germany | 22391 | |
| 53 | Pfizer Investigational Site | Hassloch | Germany | 67454 | |
| 54 | Pfizer Investigational Site | Kuenzing | Germany | 94550 | |
| 55 | Pfizer Investigational Site | Leipzig | Germany | 04103 | |
| 56 | Pfizer Investigational Site | Meissen | Germany | 01662 | |
| 57 | Pfizer Investigational Site | Mittweida | Germany | 09648 | |
| 58 | Pfizer Investigational Site | Muenster | Germany | 48145 | |
| 59 | Pfizer Investigational Site | Muenster | Germany | 48153 | |
| 60 | Pfizer Investigational Site | Offenbach | Germany | 63065 | |
| 61 | Pfizer Investigational Site | Offenburg | Germany | 77654 | |
| 62 | Pfizer Investigational Site | Oschatz | Germany | 04758 | |
| 63 | Pfizer Investigational Site | Pirna | Germany | 01796 | |
| 64 | Pfizer Investigational Site | Riedlhuette | Germany | 94566 | |
| 65 | Pfizer Investigational Site | Riesa | Germany | 01587 | |
| 66 | Pfizer Investigational Site | Rossach | Germany | 96269 | |
| 67 | Pfizer Investigational Site | Schwabenheim | Germany | 55270 | |
| 68 | Pfizer Investigational Site | St.Ingbert | Germany | 66386 | |
| 69 | Pfizer Investigational Site | Surwold | Germany | 26903 | |
| 70 | Pfizer Investigational Site | Wangen / Allgaeu | Germany | 88239 | |
| 71 | Pfizer Investigational Site | Wangen | Germany | 88239 | |
| 72 | Pfizer Investigational Site | Witten | Germany | 58455 | |
| 73 | Pfizer Investigational Site | Bari | Italy | 70124 | |
| 74 | Pfizer Investigational Site | Catania | Italy | 95122 | |
| 75 | Pfizer Investigational Site | Firenze | Italy | 50134 | |
| 76 | Pfizer Investigational Site | Genova | Italy | 16132 | |
| 77 | Pfizer Investigational Site | Milano | Italy | 20132 | |
| 78 | Pfizer Investigational Site | Napoli | Italy | 80131 | |
| 79 | Pfizer Investigational Site | Padova | Italy | 35128 | |
| 80 | Pfizer Investigational Site | Palermo | Italy | 90127 | |
| 81 | Pfizer Investigational Site | Pescara | Italy | 65100 | |
| 82 | Pfizer Investigational Site | Pisa | Italy | 56124 | |
| 83 | Pfizer Investigational Site | Roma | Italy | 00133 | |
| 84 | Pfizer Investigational Site | Torino | Italy | 10126 | |
| 85 | Pfizer Investigational Site | Udine | Italy | 33100 | |
| 86 | Pfizer Investigational Site | Verona | Italy | 37126 | |
| 87 | Pfizer Investigational Site | Badalona | Barcelona | Spain | 08916 |
| 88 | Pfizer Investigational Site | Las Palmas | Las Palmas de Gran Canaria | Spain | 35010 |
| 89 | Pfizer Investigational Site | Baracaldo | Vizcaya | Spain | 48903 |
| 90 | Pfizer Investigational Site | Bilbao | Vizcaya | Spain | 48013 |
| 91 | Pfizer Investigational Site | Barcelona | Spain | 08003 | |
| 92 | Pfizer Investigational Site | Barcelona | Spain | 08017 | |
| 93 | Pfizer Investigational Site | Barcelona | Spain | 08036 | |
| 94 | Pfizer Investigational Site | Cadiz | Spain | 11009 | |
| 95 | Pfizer Investigational Site | Gerona | Spain | 17007 | |
| 96 | Pfizer Investigational Site | Granada | Spain | 18012 | |
| 97 | Pfizer Investigational Site | Madrid | Spain | 28034 | |
| 98 | Pfizer Investigational Site | Madrid | Spain | 28040 | |
| 99 | Pfizer Investigational Site | Sevilla | Spain | 41014 | |
| 100 | Pfizer Investigational Site | Valencia | Spain | 46017 | |
| 101 | Pfizer Investigational Site | Ayr | Ayrshire | United Kingdom | KA7 1BJ |
| 102 | Pfizer Investigational Site | Thornhill | Cardiff | United Kingdom | CF14 9BB |
| 103 | Pfizer Investigational Site | Penzance | Cornwall | United Kingdom | TR18 4JH |
| 104 | Pfizer Investigational Site | St. Austell | Cornwall | United Kingdom | PL26 7RL |
| 105 | Pfizer Investigational Site | Truro | Cornwall | United Kingdom | TR1 3LJ |
| 106 | Pfizer Investigational Site | Plymouth | Devon | United Kingdom | PL6 8BX |
| 107 | Pfizer Investigational Site | Letchworth | Hertfordshire | United Kingdom | SG6 4UB |
| 108 | Pfizer Investigational Site | Sidcup | Kent | United Kingdom | DA14 6LT |
| 109 | Pfizer Investigational Site | Whitstable | Kent | United Kingdom | CT5 3QU |
| 110 | Pfizer Investigational Site | Blackpool | Lancashire | United Kingdom | FY3 7EN |
| 111 | Pfizer Investigational Site | Colney | Norwich | United Kingdom | NR4 7UY |
| 112 | Pfizer Investigational Site | Headington | Oxford | United Kingdom | OX3 7LJ |
| 113 | Pfizer Investigational Site | Penarth | South Glamorgan | United Kingdom | CF64 2XX |
| 114 | Pfizer Investigational Site | Dundee | Tayside | United Kingdom | DD1 9SY |
| 115 | Pfizer Investigational Site | Haywards Heath | West Sussex | United Kingdom | RH16 4EX |
| 116 | Pfizer Investigational Site | Birmingham | United Kingdom | B9 5SS | |
| 117 | Pfizer Investigational Site | Bolton | United Kingdom | BL3 6TL | |
| 118 | Pfizer Investigational Site | Canterbury | United Kingdom | CT1 3HX | |
| 119 | Pfizer Investigational Site | Liverpool | United Kingdom | L7 8XP | |
| 120 | Pfizer Investigational Site | Salford | United Kingdom | M6 8HD | |
| 121 | Pfizer Investigational Site | York | United Kingdom | YO31 8HE |
Sponsors and Collaborators
- Pfizer
- Sanofi
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00134147
Other Study ID Numbers:
- A2171018
First Posted:
Aug 24, 2005
Last Update Posted:
Apr 17, 2008
Last Verified:
Apr 1, 2008