FUSE: Follow-Up Study for Exubera
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00734591
Collaborator
(none)
7,439
321
41
23.2
0.6
Study Details
Study Description
Brief Summary
In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Both retrospective and prospective components All subjects who participated in one of the 17 included Exubera clinical trials will be invited to participate in the current study.
Study Design
Study Type:
Observational
Actual Enrollment
:
7439 participants
Observational Model:
Cohort
Official Title:
An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials
Study Start Date
:
Aug 1, 2008
Actual Primary Completion Date
:
Jan 1, 2012
Actual Study Completion Date
:
Jan 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Previously treated with Exubera
|
Drug: Exubera
Subjects who had been treated with Exubera in a prior Exubera controlled trial. Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
|
| Previously treated with comparator Subjects who had been treated with a comparator (other diabetes treatment such as injected insulin) in a prior Exubera controlled trial. |
Other: Randomized diabetes therapy
Subjects who had been treated with a comparator (other diabetes treatment including one or more of: subcutaneous insulin, sulfonylureas, biguanides, or thiazolinediones) in a prior Exubera controlled trial.
Following initial use of randomized treatment, physicians and subjects were free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
|
Outcome Measures
Primary Outcome Measures
- Rate of Primary Lung Cancer Mortality [Baseline from original trial up to Year 2 of this study]
Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.
Secondary Outcome Measures
- Rate of Primary Lung Cancer Mortality Among Former Smokers [Baseline from original trial up to Year 2 of this study]
Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.
- Rate of All-cause Mortality [Baseline from original trial up to Year 2 of this study]
The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.
- Rate of Primary Lung Cancer Diagnosis [Baseline from original trial up to Year 2 of this study]
The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Previously participated in an eligible Exubera clinical trial
-
Willing to provide study doctor with at least one alternate contact person
Exclusion Criteria:
-
Participated in an investigational study of an unapproved drug since completing the Exubera trial
-
Ever used an other (non-Exubera) inhaled insulin
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Bay Minette | Alabama | United States | 36507 |
| 2 | Pfizer Investigational Site | Graysville | Alabama | United States | 35073 |
| 3 | Pfizer Investigational Site | Pell City | Alabama | United States | 35125 |
| 4 | Pfizer Investigational Site | Pell City | Alabama | United States | 35128 |
| 5 | Pfizer Investigational Site | Glendale | Arizona | United States | 85306 |
| 6 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85006 |
| 7 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85016 |
| 8 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85028 |
| 9 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85051 |
| 10 | Pfizer Investigational Site | Forrest City | Arkansas | United States | 72335 |
| 11 | Pfizer Investigational Site | Berkeley | California | United States | 94705 |
| 12 | Pfizer Investigational Site | Concord | California | United States | 94520 |
| 13 | Pfizer Investigational Site | El Cajon | California | United States | 92019 |
| 14 | Pfizer Investigational Site | Encino | California | United States | 91436 |
| 15 | Pfizer Investigational Site | Fresno | California | United States | 93720 |
| 16 | Pfizer Investigational Site | Fullerton | California | United States | 92835 |
| 17 | Pfizer Investigational Site | Huntington Beach | California | United States | 92648 |
| 18 | Pfizer Investigational Site | Long Beach | California | United States | 90806 |
| 19 | Pfizer Investigational Site | Los Angeles | California | United States | 90073 |
| 20 | Pfizer Investigational Site | Rolling Hills Estates | California | United States | 90274 |
| 21 | Pfizer Investigational Site | San Diego | California | United States | 92120 |
| 22 | Pfizer Investigational Site | San Diego | California | United States | 92128 |
| 23 | Pfizer Investigational Site | San Jose | California | United States | 95116 |
| 24 | Pfizer Investigational Site | Santa Ana | California | United States | 92704 |
| 25 | Pfizer Investigational Site | Santa Barbara | California | United States | 93105 |
| 26 | Pfizer Investigational Site | Tustin | California | United States | 92780 |
| 27 | Pfizer Investigational Site | Denver | Colorado | United States | 80206 |
| 28 | Pfizer Investigational Site | Denver | Colorado | United States | 80209 |
| 29 | Pfizer Investigational Site | Denver | Colorado | United States | 80220 |
| 30 | Pfizer Investigational Site | Golden | Colorado | United States | 80401 |
| 31 | Pfizer Investigational Site | Longmont | Colorado | United States | 80501 |
| 32 | Pfizer Investigational Site | Milford | Connecticut | United States | 06460 |
| 33 | Pfizer Investigational Site | Newark | Delaware | United States | 19713 |
| 34 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20010 |
| 35 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20307 |
| 36 | Pfizer Investigational Site | Boca Raton | Florida | United States | 33433 |
| 37 | Pfizer Investigational Site | Chiefland | Florida | United States | 32626 |
| 38 | Pfizer Investigational Site | Green Cove Springs | Florida | United States | 32043 |
| 39 | Pfizer Investigational Site | Kissimmee | Florida | United States | 34743 |
| 40 | Pfizer Investigational Site | Lake City | Florida | United States | 32025 |
| 41 | Pfizer Investigational Site | Lake Mary | Florida | United States | 32746 |
| 42 | Pfizer Investigational Site | Miami | Florida | United States | 33136 |
| 43 | Pfizer Investigational Site | Opa Locka | Florida | United States | 33054-3818 |
| 44 | Pfizer Investigational Site | St. Cloud | Florida | United States | 34769 |
| 45 | Pfizer Investigational Site | Tampa | Florida | United States | 33624 |
| 46 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33401 |
| 47 | Pfizer Investigational Site | Atlanta | Georgia | United States | 30318-2513 |
| 48 | Pfizer Investigational Site | Atlanta | Georgia | United States | 30342 |
| 49 | Pfizer Investigational Site | Conyers | Georgia | United States | 30013 |
| 50 | Pfizer Investigational Site | Decatur | Georgia | United States | 30035 |
| 51 | Pfizer Investigational Site | Honolulu | Hawaii | United States | 96813 |
| 52 | Pfizer Investigational Site | Honolulu | Hawaii | United States | 96814 |
| 53 | Pfizer Investigational Site | Hayden Lake | Idaho | United States | 83835 |
| 54 | Pfizer Investigational Site | Greenville | Illinois | United States | 62246 |
| 55 | Pfizer Investigational Site | Normal | Illinois | United States | 61761 |
| 56 | Pfizer Investigational Site | Olympia Fields | Illinois | United States | 60461 |
| 57 | Pfizer Investigational Site | Springfield | Illinois | United States | 62704 |
| 58 | Pfizer Investigational Site | Fishers | Indiana | United States | 46038 |
| 59 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46229 |
| 60 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46254-5472 |
| 61 | Pfizer Investigational Site | Des Moines | Iowa | United States | 50314 |
| 62 | Pfizer Investigational Site | Des Moines | Iowa | United States | 50315 |
| 63 | Pfizer Investigational Site | Dubuque | Iowa | United States | 52002 |
| 64 | Pfizer Investigational Site | Wichita | Kansas | United States | 67203 |
| 65 | Pfizer Investigational Site | Louisville | Kentucky | United States | 40213 |
| 66 | Pfizer Investigational Site | Louisville | Kentucky | United States | 40258 |
| 67 | Pfizer Investigational Site | Mount Sterling | Kentucky | United States | 40353 |
| 68 | Pfizer Investigational Site | Baltimore | Maryland | United States | 21204 |
| 69 | Pfizer Investigational Site | Elkton | Maryland | United States | 21921 |
| 70 | Pfizer Investigational Site | Glen Burnie | Maryland | United States | 21061 |
| 71 | Pfizer Investigational Site | Wheaton | Maryland | United States | 20902 |
| 72 | Pfizer Investigational Site | Boston | Massachusetts | United States | 02114 |
| 73 | Pfizer Investigational Site | Springfield | Massachusetts | United States | 01105 |
| 74 | Pfizer Investigational Site | Ann Arbor | Michigan | United States | 48104 |
| 75 | Pfizer Investigational Site | Clinton | Michigan | United States | 49236 |
| 76 | Pfizer Investigational Site | Flint | Michigan | United States | 48532 |
| 77 | Pfizer Investigational Site | Muskegon | Michigan | United States | 49444 |
| 78 | Pfizer Investigational Site | Saint Cloud | Minnesota | United States | 56301 |
| 79 | Pfizer Investigational Site | Kansas City | Missouri | United States | 64116 |
| 80 | Pfizer Investigational Site | Springfield | Missouri | United States | 65807 |
| 81 | Pfizer Investigational Site | Incline Village | Nevada | United States | 89452 |
| 82 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89128 |
| 83 | Pfizer Investigational Site | Belvidere | New Jersey | United States | 07823 |
| 84 | Pfizer Investigational Site | New Brunswick | New Jersey | United States | 08901 |
| 85 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87106 |
| 86 | Pfizer Investigational Site | Albany | New York | United States | 12208 |
| 87 | Pfizer Investigational Site | Babylon | New York | United States | 11702 |
| 88 | Pfizer Investigational Site | Brooklyn | New York | United States | 11224 |
| 89 | Pfizer Investigational Site | Minneola | New York | United States | 11501 |
| 90 | Pfizer Investigational Site | New Hartford | New York | United States | 13413 |
| 91 | Pfizer Investigational Site | Syracuse | New York | United States | 13210 |
| 92 | Pfizer Investigational Site | Williamsville | New York | United States | 14221 |
| 93 | Pfizer Investigational Site | Asheboro | North Carolina | United States | 27203 |
| 94 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28227 |
| 95 | Pfizer Investigational Site | Durham | North Carolina | United States | 27713 |
| 96 | Pfizer Investigational Site | Morehead City | North Carolina | United States | 28557-3126 |
| 97 | Pfizer Investigational Site | Raleigh | North Carolina | United States | 27609 |
| 98 | Pfizer Investigational Site | Tabor City | North Carolina | United States | 28463 |
| 99 | Pfizer Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 100 | Pfizer Investigational Site | Columbus | Ohio | United States | 43207 |
| 101 | Pfizer Investigational Site | Dayton | Ohio | United States | 45419 |
| 102 | Pfizer Investigational Site | Kettering | Ohio | United States | 45429 |
| 103 | Pfizer Investigational Site | Marietta | Ohio | United States | 45750 |
| 104 | Pfizer Investigational Site | Portland | Oregon | United States | 97210 |
| 105 | Pfizer Investigational Site | Portland | Oregon | United States | 97232 |
| 106 | Pfizer Investigational Site | Fogelsville | Pennsylvania | United States | 18051 |
| 107 | Pfizer Investigational Site | Hanover | Pennsylvania | United States | 17331 |
| 108 | Pfizer Investigational Site | Harrisburg | Pennsylvania | United States | 17112 |
| 109 | Pfizer Investigational Site | Jeannette | Pennsylvania | United States | 15644 |
| 110 | Pfizer Investigational Site | Jersey Shore | Pennsylvania | United States | 17740 |
| 111 | Pfizer Investigational Site | Lansdale | Pennsylvania | United States | 19446 |
| 112 | Pfizer Investigational Site | Melrose Park | Pennsylvania | United States | 19027 |
| 113 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19153-2326 |
| 114 | Pfizer Investigational Site | Charleston | South Carolina | United States | 29412 |
| 115 | Pfizer Investigational Site | North Myrtle Beach | South Carolina | United States | 29582 |
| 116 | Pfizer Investigational Site | Beaumont | Texas | United States | 77701 |
| 117 | Pfizer Investigational Site | Dallas | Texas | United States | 75246 |
| 118 | Pfizer Investigational Site | Houston | Texas | United States | 77008 |
| 119 | Pfizer Investigational Site | Houston | Texas | United States | 77079 |
| 120 | Pfizer Investigational Site | Kaufman | Texas | United States | 75142 |
| 121 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229 |
| 122 | Pfizer Investigational Site | San Marcos | Texas | United States | 78666 |
| 123 | Pfizer Investigational Site | Stephenville | Texas | United States | 76401 |
| 124 | Pfizer Investigational Site | Webster | Texas | United States | 77598 |
| 125 | Pfizer Investigational Site | South Burlington | Vermont | United States | 05403 |
| 126 | Pfizer Investigational Site | Richmond | Virginia | United States | 23225-4017 |
| 127 | Pfizer Investigational Site | Richmond | Virginia | United States | 23294 |
| 128 | Pfizer Investigational Site | Federal Way | Washington | United States | 98003 |
| 129 | Pfizer Investigational Site | Spokane | Washington | United States | 99204 |
| 130 | Pfizer Investigational Site | Spokane | Washington | United States | 99207 |
| 131 | Pfizer Investigational Site | Burnsville | West Virginia | United States | 26335 |
| 132 | Pfizer Investigational Site | Capital Federal | Buenos Aires | Argentina | C1181ACH |
| 133 | Pfizer Investigational Site | Buenos Aires | Argentina | C1426ABP | |
| 134 | Pfizer Investigational Site | Camperdown | New South Wales | Australia | 2050 |
| 135 | Pfizer Investigational Site | Wollongong | New South Wales | Australia | 2500 |
| 136 | Pfizer Investigational Site | Herston | Queensland | Australia | 4029 |
| 137 | Pfizer Investigational Site | Box Hill | Victoria | Australia | 3128 |
| 138 | Pfizer Investigational Site | Melbourne | Victoria | Australia | 3004 |
| 139 | Pfizer Investigational Site | Vienna | Austria | A-1130 | |
| 140 | Pfizer Investigational Site | Wien | Austria | A-1030 | |
| 141 | Pfizer Investigational Site | Bornem | Belgium | 2880 | |
| 142 | Pfizer Investigational Site | Brussels | Belgium | 1070 | |
| 143 | Pfizer Investigational Site | Edegem | Belgium | 2650 | |
| 144 | Pfizer Investigational Site | Genk | Belgium | 3600 | |
| 145 | Pfizer Investigational Site | Leuven | Belgium | 3000 | |
| 146 | Pfizer Investigational Site | Liège 1 | Belgium | 4000 | |
| 147 | Pfizer Investigational Site | Belo Horizonte | MG | Brazil | 30150-221 |
| 148 | Pfizer Investigational Site | Porto Alegre | RS | Brazil | 90035-170 |
| 149 | Pfizer Investigational Site | Sao Paulo | SP | Brazil | 01244-030 |
| 150 | Pfizer Investigational Site | Sao Paulo | SP | Brazil | 04025-011 |
| 151 | Pfizer Investigational Site | Calgary | Alberta | Canada | T2L 1K8 |
| 152 | Pfizer Investigational Site | Calgary | Alberta | Canada | T2T 5C7 |
| 153 | Pfizer Investigational Site | Calgary | Alberta | Canada | T3B 0M3 |
| 154 | Pfizer Investigational Site | Edmonton | Alberta | Canada | T5J 3N4 |
| 155 | Pfizer Investigational Site | Edmonton | Alberta | Canada | T6G 2C8 |
| 156 | Pfizer Investigational Site | Edmonton | Alberta | Canada | T6G 2S2 |
| 157 | Pfizer Investigational Site | Red Deer | Alberta | Canada | T6N 6V7 |
| 158 | Pfizer Investigational Site | Victoria | British Columbia | Canada | V8R 1J8 |
| 159 | Pfizer Investigational Site | Winnipeg | Manitoba | Canada | R3E 3P4 |
| 160 | Pfizer Investigational Site | St. John's | Newfoundland and Labrador | Canada | A1A 2E2 |
| 161 | Pfizer Investigational Site | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 162 | Pfizer Investigational Site | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 163 | Pfizer Investigational Site | Corunna | Ontario | Canada | N0N 1G0 |
| 164 | Pfizer Investigational Site | London | Ontario | Canada | N6A 4V2 |
| 165 | Pfizer Investigational Site | Mississauga | Ontario | Canada | L5M 2V8 |
| 166 | Pfizer Investigational Site | Oakville | Ontario | Canada | L6H 3P1 |
| 167 | Pfizer Investigational Site | Ottawa | Ontario | Canada | K1H 1A2 |
| 168 | Pfizer Investigational Site | Smiths Falls | Ontario | Canada | K7A 4W8 |
| 169 | Pfizer Investigational Site | Thornhill | Ontario | Canada | L4J 8L7 |
| 170 | Pfizer Investigational Site | Toronto | Ontario | Canada | M4N-3M5 |
| 171 | Pfizer Investigational Site | Toronto | Ontario | Canada | M4R 2G4 |
| 172 | Pfizer Investigational Site | Chicoutimi | Quebec | Canada | G7H 5H6 |
| 173 | Pfizer Investigational Site | Gatineau | Quebec | Canada | J8Y 6S9 |
| 174 | Pfizer Investigational Site | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 175 | Pfizer Investigational Site | Laval | Quebec | Canada | H7T 2P5 |
| 176 | Pfizer Investigational Site | Montreal | Quebec | Canada | H3A 1A1 |
| 177 | Pfizer Investigational Site | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 178 | Pfizer Investigational Site | Trois Rivieres | Quebec | Canada | G8T 7A1 |
| 179 | Pfizer Investigational Site | Zagreb | Croatia | 10 000 | |
| 180 | Pfizer Investigational Site | Zagreb | Croatia | 10000 | |
| 181 | Pfizer Investigational Site | Aarhus | Denmark | 8000 | |
| 182 | Pfizer Investigational Site | Copenhagen | Denmark | 2400 | |
| 183 | Pfizer Investigational Site | Herning | Denmark | 7400 | |
| 184 | Pfizer Investigational Site | Viljandi | Viljandi mk. | Estonia | 71024 |
| 185 | Pfizer Investigational Site | Pärnu | Estonia | 80018 | |
| 186 | Pfizer Investigational Site | Tallinn | Estonia | 10318 | |
| 187 | Pfizer Investigational Site | Tallinn | Estonia | 11625 | |
| 188 | Pfizer Investigational Site | Tallinn | Estonia | 13415 | |
| 189 | Pfizer Investigational Site | Kuopio | Finland | 70210 | |
| 190 | Pfizer Investigational Site | Lahti | Finland | 15110 | |
| 191 | Pfizer Investigational Site | Lohja | Finland | 08200 | |
| 192 | Pfizer Investigational Site | Oulu | Finland | 90100 | |
| 193 | Pfizer Investigational Site | Amiens cedex 1 | France | 80094 | |
| 194 | Pfizer Investigational Site | Armentieres | France | 59427 | |
| 195 | Pfizer Investigational Site | Besancon | France | 25030 | |
| 196 | Pfizer Investigational Site | Bondy Cedex | France | 93143 | |
| 197 | Pfizer Investigational Site | Brest CEDEX | France | 29609 | |
| 198 | Pfizer Investigational Site | Chartres | France | 28000 | |
| 199 | Pfizer Investigational Site | Corbeil-Essonnes | France | 91100 | |
| 200 | Pfizer Investigational Site | Lorient Cedex | France | 56322 | |
| 201 | Pfizer Investigational Site | Paris Cedex 10 | France | 75475 | |
| 202 | Pfizer Investigational Site | Paris Cedex 18 | France | 75877 | |
| 203 | Pfizer Investigational Site | Rennes Cedex 2 | France | 35203 | |
| 204 | Pfizer Investigational Site | Altenburg | Germany | 04600 | |
| 205 | Pfizer Investigational Site | Aschaffenburg | Germany | 63739 | |
| 206 | Pfizer Investigational Site | Bad Doberan | Germany | 18209 | |
| 207 | Pfizer Investigational Site | Berlin | Germany | 10115 | |
| 208 | Pfizer Investigational Site | Berlin | Germany | 13355 | |
| 209 | Pfizer Investigational Site | Bonn | Germany | 53179 | |
| 210 | Pfizer Investigational Site | Chemnitz | Germany | 09130 | |
| 211 | Pfizer Investigational Site | Datteln | Germany | 45711 | |
| 212 | Pfizer Investigational Site | Dortmund | Germany | 44339 | |
| 213 | Pfizer Investigational Site | Eisenach | Germany | 99817 | |
| 214 | Pfizer Investigational Site | Emden | Germany | 26725 | |
| 215 | Pfizer Investigational Site | Essen | Germany | 45329 | |
| 216 | Pfizer Investigational Site | Falkensee | Germany | 14612 | |
| 217 | Pfizer Investigational Site | Friedberg | Germany | 86316 | |
| 218 | Pfizer Investigational Site | Fulda | Germany | 36037 | |
| 219 | Pfizer Investigational Site | Hamburg | Germany | 21073 | |
| 220 | Pfizer Investigational Site | Hohenmoelsen | Germany | 06679 | |
| 221 | Pfizer Investigational Site | Leipzig | Germany | 04103 | |
| 222 | Pfizer Investigational Site | Leverkusen | Germany | 51371 | |
| 223 | Pfizer Investigational Site | Marl | Germany | 45770 | |
| 224 | Pfizer Investigational Site | Meissen | Germany | 01662 | |
| 225 | Pfizer Investigational Site | Mittweida | Germany | 09648 | |
| 226 | Pfizer Investigational Site | Muenchen | Germany | D-80469 | |
| 227 | Pfizer Investigational Site | Muenster | Germany | 48145 | |
| 228 | Pfizer Investigational Site | Muenster | Germany | 48153 | |
| 229 | Pfizer Investigational Site | Neuss | Germany | 41460 | |
| 230 | Pfizer Investigational Site | Reinfeld | Germany | 23858 | |
| 231 | Pfizer Investigational Site | Riesa | Germany | 01587 | |
| 232 | Pfizer Investigational Site | Rossach | Germany | 96269 | |
| 233 | Pfizer Investigational Site | Schluechtern | Germany | 36381 | |
| 234 | Pfizer Investigational Site | Siegen | Germany | 57072 | |
| 235 | Pfizer Investigational Site | Suhl | Germany | 98529 | |
| 236 | Pfizer Investigational Site | Surwold | Germany | 26903 | |
| 237 | Pfizer Investigational Site | Villingen-Schwenningen | Germany | 78054 | |
| 238 | Pfizer Investigational Site | Wangen / Allgaeu | Germany | 88239 | |
| 239 | Pfizer Investigational Site | Wangen | Germany | 88239 | |
| 240 | Pfizer Investigational Site | Warburg | Germany | 34414 | |
| 241 | Pfizer Investigational Site | Wiesbaden | Germany | 65191 | |
| 242 | Pfizer Investigational Site | Athens | Greece | 11527 | |
| 243 | Pfizer Investigational Site | Athens | Greece | 15123 | |
| 244 | Pfizer Investigational Site | Thessaloniki | Greece | 546 36 | |
| 245 | Pfizer Investigational Site | Catania | Italy | 95122 | |
| 246 | Pfizer Investigational Site | Genova | Italy | 16132 | |
| 247 | Pfizer Investigational Site | Milano | Italy | 20132 | |
| 248 | Pfizer Investigational Site | Napoli | Italy | 80131 | |
| 249 | Pfizer Investigational Site | Padova | Italy | 35128 | |
| 250 | Pfizer Investigational Site | Palermo | Italy | 90127 | |
| 251 | Pfizer Investigational Site | Roma | Italy | 00133 | |
| 252 | Pfizer Investigational Site | Udine | Italy | 33100 | |
| 253 | Pfizer Investigational Site | Guadalajara | Jalisco | Mexico | 44340 |
| 254 | Pfizer Investigational Site | Monterrey | Nuevo Leon | Mexico | 64460 |
| 255 | Pfizer Investigational Site | 's Hertogenbosch | Netherlands | 5211 RW | |
| 256 | Pfizer Investigational Site | Amsterdam | Netherlands | 1105 AZ | |
| 257 | Pfizer Investigational Site | Beek | Netherlands | 6191 JW | |
| 258 | Pfizer Investigational Site | Eindhoven | Netherlands | 5631 BM | |
| 259 | Pfizer Investigational Site | Venlo | Netherlands | 5912 BL | |
| 260 | Pfizer Investigational Site | Fornebu | Norway | 1364 | |
| 261 | Pfizer Investigational Site | Honefoss | Norway | 3515 | |
| 262 | Pfizer Investigational Site | Skedsmokorset | Norway | N-2020 | |
| 263 | Pfizer Investigational Site | Stavanger | Norway | 4068 | |
| 264 | Pfizer Investigational Site | Lask | Poland | 98-100 | |
| 265 | Pfizer Investigational Site | Lodz | Poland | 93-338 | |
| 266 | Pfizer Investigational Site | Lublin | Poland | 20-536 | |
| 267 | Pfizer Investigational Site | Warszawa | Poland | 02-097 | |
| 268 | Pfizer Investigational Site | Aveiro | Portugal | 3814-096 | |
| 269 | Pfizer Investigational Site | Lisboa | Portugal | 1250-203 | |
| 270 | Pfizer Investigational Site | Lisboa | Portugal | 1349-019 | |
| 271 | Pfizer Investigational Site | Porto | Portugal | 4099-001 | |
| 272 | Pfizer Investigational Site | Torres Vedras | Portugal | 2560-324 | |
| 273 | Pfizer Investigational Site | Banska Bystrica | Slovakia | 975 17 | |
| 274 | Pfizer Investigational Site | Bratislava | Slovakia | 811 08 | |
| 275 | Pfizer Investigational Site | Martin | Slovakia | 036 01 | |
| 276 | Pfizer Investigational Site | Houghton | Gauteng | South Africa | 2198 |
| 277 | Pfizer Investigational Site | Umhlanga Rocks | KwaZulu Natal | South Africa | 4320 |
| 278 | Pfizer Investigational Site | Santiago de Compostela | A Coruña | Spain | 15706 |
| 279 | Pfizer Investigational Site | Badalona | Barcelona | Spain | 08916 |
| 280 | Pfizer Investigational Site | Las Palmas | Las Palmas de Gran Canaria | Spain | 35016 |
| 281 | Pfizer Investigational Site | La Laguna | Santa Cruz de Tenerife | Spain | 38320 |
| 282 | Pfizer Investigational Site | Alzira | Valencia | Spain | 46600 |
| 283 | Pfizer Investigational Site | Bilbao | Vizcaya | Spain | 48013 |
| 284 | Pfizer Investigational Site | Barcelona | Spain | 08036 | |
| 285 | Pfizer Investigational Site | Granada | Spain | 18012 | |
| 286 | Pfizer Investigational Site | Madrid | Spain | 28935 | |
| 287 | Pfizer Investigational Site | Malaga | Spain | 07300 | |
| 288 | Pfizer Investigational Site | Sevilla | Spain | 41014 | |
| 289 | Pfizer Investigational Site | Valencia | Spain | 46015 | |
| 290 | Pfizer Investigational Site | Boras | Sweden | 503 30 | |
| 291 | Pfizer Investigational Site | Forshaga | Sweden | 667 32 | |
| 292 | Pfizer Investigational Site | Goteborg | Sweden | 412 55 | |
| 293 | Pfizer Investigational Site | Goteborg | Sweden | 41665 | |
| 294 | Pfizer Investigational Site | Göteborg | Sweden | 417 17 | |
| 295 | Pfizer Investigational Site | Harnosand | Sweden | 871 82 | |
| 296 | Pfizer Investigational Site | Helsingborg | Sweden | 251 87 | |
| 297 | Pfizer Investigational Site | Linkoping | Sweden | 581 85 | |
| 298 | Pfizer Investigational Site | Malmo | Sweden | 211 52 | |
| 299 | Pfizer Investigational Site | Stockholm | Sweden | 171 76 | |
| 300 | Pfizer Investigational Site | Vaxjo | Sweden | 351 85 | |
| 301 | Pfizer Investigational Site | Penzance | Cornwall | United Kingdom | TR18 4JH |
| 302 | Pfizer Investigational Site | St. Austell | Cornwall | United Kingdom | PL26 7RL |
| 303 | Pfizer Investigational Site | Plymouth | Devon | United Kingdom | PL6 8BX |
| 304 | Pfizer Investigational Site | Letchworth | Hertfordshire | United Kingdom | SG6 4UB |
| 305 | Pfizer Investigational Site | Ashford | Middlesex | United Kingdom | TW15 3EA |
| 306 | Pfizer Investigational Site | Headington | Oxford | United Kingdom | OX3 7LJ |
| 307 | Pfizer Investigational Site | Weybridge | Surrey | United Kingdom | KT15 2BH |
| 308 | Pfizer Investigational Site | Woking | Surrey | United Kingdom | GU22 7EY |
| 309 | Pfizer Investigational Site | Rugby | Warwickshire | United Kingdom | CV22 5PX |
| 310 | Pfizer Investigational Site | Warminster | Wiltshire | United Kingdom | BA12 9AA |
| 311 | Pfizer Investigational Site | Sheffield | Yorkshire | United Kingdom | S7 2DW |
| 312 | Pfizer Investigational Site | Bath | United Kingdom | BA2 3HT | |
| 313 | Pfizer Investigational Site | Bath | United Kingdom | BA2 4BY | |
| 314 | Pfizer Investigational Site | Birmingham | United Kingdom | B37 7TR | |
| 315 | Pfizer Investigational Site | Birmingham | United Kingdom | B9 5SS | |
| 316 | Pfizer Investigational Site | Bolton | United Kingdom | BL3 6TL | |
| 317 | Pfizer Investigational Site | Canterbury | United Kingdom | CT1 3HX | |
| 318 | Pfizer Investigational Site | Leicester | United Kingdom | LE1 5WW | |
| 319 | Pfizer Investigational Site | Newcastle-upon-Tyne | United Kingdom | NE15 6TQ | |
| 320 | Pfizer Investigational Site | Salford | United Kingdom | M6 8HD | |
| 321 | Pfizer Investigational Site | Westbury | United Kingdom | BA13 3JD |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00734591
Other Study ID Numbers:
- A2171121
First Posted:
Aug 14, 2008
Last Update Posted:
Oct 23, 2012
Last Verified:
Sep 1, 2012
Keywords provided by Pfizer
Study Results
Participant Flow
| Recruitment Details | This study had retrospective and prospective components. Individuals who participated in Exubera-controlled trials that were still active in 2003 or later participated in the retrospective part of this study (Follow-Up Study for Exubera; FUSE). Individuals from sites participating in the prospective part of FUSE were eligible. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Previously Randomized to Exubera | Previously Randomized to Comparator |
|---|---|---|
| Arm/Group Description | Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. | Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. |
| Period Title: Retrospective Period | ||
| STARTED | 3875 | 3564 |
| COMPLETED | 3875 | 3564 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Retrospective Period | ||
| STARTED | 3875 | 3564 |
| COMPLETED | 1358 | 1273 |
| NOT COMPLETED | 2517 | 2291 |
| Period Title: Retrospective Period | ||
| STARTED | 1358 | 1273 |
| COMPLETED | 1307 | 1229 |
| NOT COMPLETED | 51 | 44 |
Baseline Characteristics
| Arm/Group Title | Previously Randomized to Exubera | Previously Randomized to Comparator | Total |
|---|---|---|---|
| Arm/Group Description | Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. | Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. | Total of all reporting groups |
| Overall Participants | 3875 | 3564 | 7439 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
54.8
(12.1)
|
54.7
(12.6)
|
54.8
(12.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1677
43.3%
|
1557
43.7%
|
3234
43.5%
|
| Male |
2198
56.7%
|
2007
56.3%
|
4205
56.5%
|
| Smoking status (participants) [Number] | |||
| Never-smoker |
2194
56.6%
|
2031
57%
|
4225
56.8%
|
| Ever-smoker |
1681
43.4%
|
1533
43%
|
3214
43.2%
|
Outcome Measures
| Title | Rate of Primary Lung Cancer Mortality |
|---|---|
| Description | Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE. |
| Time Frame | Baseline from original trial up to Year 2 of this study |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entire study population: all randomized participants (retrospective). |
| Arm/Group Title | Previously Randomized to Exubera | Previously Randomized to Comparator |
|---|---|---|
| Arm/Group Description | Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. | Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. |
| Measure Participants | 3875 | 3654 |
| Number (95% Confidence Interval) [Deaths per 1000 patient years (PY)] |
0.48
|
0.17
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Previously Randomized to Exubera, Previously Randomized to Comparator |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Exact method |
| Estimated Value | 2.81 | |
| Confidence Interval |
(2-Sided) 95% 0.50 to 28.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures. | |
| Title | Rate of Primary Lung Cancer Mortality Among Former Smokers |
|---|---|
| Description | Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE. |
| Time Frame | Baseline from original trial up to Year 2 of this study |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subset of the entire study population who were former smokers. |
| Arm/Group Title | Previously Randomized to Exubera | Previously Randomized to Comparator |
|---|---|---|
| Arm/Group Description | Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. | Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. |
| Measure Participants | 1681 | 1533 |
| Number (95% Confidence Interval) [Deaths per 1000 PY] |
0.94
|
0.41
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Previously Randomized to Exubera, Previously Randomized to Comparator |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Exact method |
| Estimated Value | 2.29 | |
| Confidence Interval |
(2-Sided) 95% 0.37 to 24.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures. | |
| Title | Rate of All-cause Mortality |
|---|---|
| Description | The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE. |
| Time Frame | Baseline from original trial up to Year 2 of this study |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entire study population |
| Arm/Group Title | Previously Randomized to Exubera | Previously Randomized to Comparator |
|---|---|---|
| Arm/Group Description | Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. | Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. |
| Measure Participants | 3875 | 3564 |
| Number (95% Confidence Interval) [Deaths per 1000 PY] |
6.03
|
7.37
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Previously Randomized to Exubera, Previously Randomized to Comparator |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.81 | |
| Confidence Interval |
(2-Sided) 95% 0.60 to 1.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Rate of Primary Lung Cancer Diagnosis |
|---|---|
| Description | The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE. |
| Time Frame | Baseline from original trial up to Year 2 of this study |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entire study population |
| Arm/Group Title | Previously Randomized to Exubera | Previously Randomized to Comparator |
|---|---|---|
| Arm/Group Description | Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. | Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. |
| Measure Participants | 3875 | 3564 |
| Number (95% Confidence Interval) [Lung Cancer per 1000 PY] |
1.07
|
0.29
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Previously Randomized to Exubera, Previously Randomized to Comparator |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Exact method |
| Estimated Value | 3.75 | |
| Confidence Interval |
(2-Sided) 95% 1.01 to 20.68 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures. | |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were not collected. | |||
| Arm/Group Title | Previously Randomized to Exubera | Previously Randomized to Comparator | ||
| Arm/Group Description | Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. | Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice. | ||
All Cause Mortality |
||||
| Previously Randomized to Exubera | Previously Randomized to Comparator | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Previously Randomized to Exubera | Previously Randomized to Comparator | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Previously Randomized to Exubera | Previously Randomized to Comparator | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
Detection and/or reporting bias possible in continuous analysis (presented here) of lung cancer mortality and lung cancer incidence endpoints. Study had insufficient power to draw clear statistical conclusions due to small number of events.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00734591
Other Study ID Numbers:
- A2171121
First Posted:
Aug 14, 2008
Last Update Posted:
Oct 23, 2012
Last Verified:
Sep 1, 2012