- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00136916
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes
Efficacy and Safety of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 2 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial
This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.
This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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RS
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Porto Alegre, RS, Brasilia, 90035-170
- Pfizer Investigational Site
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SP
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Sao Paulo, SP, Brasilia, 01244-030
- Pfizer Investigational Site
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Alberta
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Calgary, Alberta, Kanada, T2T 5C7
- Pfizer Investigational Site
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Calgary, Alberta, Kanada, T3B 0M3
- Pfizer Investigational Site
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Red Deer, Alberta, Kanada, T4N 6V7
- Pfizer Investigational Site
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British Columbia
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Victoria, British Columbia, Kanada, V8R 1J8
- Pfizer Investigational Site
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Manitoba
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Winnepeg, Manitoba, Kanada, R3A 1R9
- Pfizer Investigational Site
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Winnipeg, Manitoba, Kanada, R3E 3P4
- Pfizer Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 1V7
- Pfizer Investigational Site
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Halifax, Nova Scotia, Kanada, B3H 2Y9
- Pfizer Investigational Site
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Ontario
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London, Ontario, Kanada, N6A 4V2
- Pfizer Investigational Site
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Ottawa, Ontario, Kanada, K1H 1A2
- Pfizer Investigational Site
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Toronto, Ontario, Kanada, M4N-3M5
- Pfizer Investigational Site
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Toronto, Ontario, Kanada, M5G 1X5
- Pfizer Investigational Site
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Quebec
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Laval, Quebec, Kanada, H7T 2P5
- Pfizer Investigational Site
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Montreal, Quebec, Kanada, H3A 1A1
- Pfizer Investigational Site
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Montreal, Quebec, Kanada, H1T 2M4
- Pfizer Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7N 0W8
- Pfizer Investigational Site
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Aguas Buenas, Puerto Rico, 00703
- Pfizer Investigational Site
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Anasco, Puerto Rico, 00610
- Pfizer Investigational Site
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Cabo Rojo, Puerto Rico, 00623
- Pfizer Investigational Site
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San Juan, Puerto Rico, 00909
- Pfizer Investigational Site
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San Juan, Puerto Rico, 00921
- Pfizer Investigational Site
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Arizona
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Phoenix, Arizona, Yhdysvallat, 85016
- Pfizer Investigational Site
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Tucson, Arizona, Yhdysvallat, 85715
- Pfizer Investigational Site
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California
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Fresno, California, Yhdysvallat, 93720
- Pfizer Investigational Site
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Greenbrae, California, Yhdysvallat, 94904
- Pfizer Investigational Site
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Los Angeles, California, Yhdysvallat, 90073
- Pfizer Investigational Site
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Sacramento, California, Yhdysvallat, 95816
- Pfizer Investigational Site
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San Diego, California, Yhdysvallat, 92108
- Pfizer Investigational Site
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San Diego, California, Yhdysvallat, 92103
- Pfizer Investigational Site
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San Luis Obispo, California, Yhdysvallat, 93401
- Pfizer Investigational Site
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Tustin, California, Yhdysvallat, 92780
- Pfizer Investigational Site
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Walnut Creek, California, Yhdysvallat, 94598
- Pfizer Investigational Site
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Colorado
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Denver, Colorado, Yhdysvallat, 80209
- Pfizer Investigational Site
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Connecticut
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Hamden, Connecticut, Yhdysvallat, 06518
- Pfizer Investigational Site
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Madison, Connecticut, Yhdysvallat, 06443
- Pfizer Investigational Site
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New Britain, Connecticut, Yhdysvallat, 06050
- Pfizer Investigational Site
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Waterbury, Connecticut, Yhdysvallat, 06708
- Pfizer Investigational Site
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Florida
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Chiefland, Florida, Yhdysvallat, 32626
- Pfizer Investigational Site
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Clearwater, Florida, Yhdysvallat, 33761
- Pfizer Investigational Site
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Fort Myers, Florida, Yhdysvallat, 33901
- Pfizer Investigational Site
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Hollywood, Florida, Yhdysvallat, 33021
- Pfizer Investigational Site
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Miami, Florida, Yhdysvallat, 33156
- Pfizer Investigational Site
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Ocala, Florida, Yhdysvallat, 34471
- Pfizer Investigational Site
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Palm Harbor, Florida, Yhdysvallat, 34684
- Pfizer Investigational Site
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Tallahassee, Florida, Yhdysvallat, 32308
- Pfizer Investigational Site
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West Palm Beach, Florida, Yhdysvallat, 33401
- Pfizer Investigational Site
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Hawaii
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Honolulu, Hawaii, Yhdysvallat, 96813
- Pfizer Investigational Site
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Honolulu, Hawaii, Yhdysvallat, 96814
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, Yhdysvallat, 60607
- Pfizer Investigational Site
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Chicago, Illinois, Yhdysvallat, 60610
- Pfizer Investigational Site
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Chicago, Illinois, Yhdysvallat, 60602
- Pfizer Investigational Site
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Springfield, Illinois, Yhdysvallat, 62704
- Pfizer Investigational Site
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Wilmette, Illinois, Yhdysvallat, 60091
- Pfizer Investigational Site
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Louisiana
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New Orleans, Louisiana, Yhdysvallat, 70112
- Pfizer Investigational Site
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Maryland
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Bethesda, Maryland, Yhdysvallat, 20817
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02215
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48106
- Pfizer Investigational Site
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Bloomfield Hills, Michigan, Yhdysvallat, 48302
- Pfizer Investigational Site
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Plymouth, Michigan, Yhdysvallat, 48170
- Pfizer Investigational Site
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Royal Oak, Michigan, Yhdysvallat, 48073
- Pfizer Investigational Site
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Southfield, Michigan, Yhdysvallat, 48034
- Pfizer Investigational Site
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Missouri
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Chesterfield, Missouri, Yhdysvallat, 63017
- Pfizer Investigational Site
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St. Louis, Missouri, Yhdysvallat, 63141
- Pfizer Investigational Site
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Montana
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Butte, Montana, Yhdysvallat, 59701
- Pfizer Investigational Site
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Nebraska
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Lincoln, Nebraska, Yhdysvallat, 68521
- Pfizer Investigational Site
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Nevada
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Henderson, Nevada, Yhdysvallat, 89014
- Pfizer Investigational Site
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New Mexico
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Albuquerque, New Mexico, Yhdysvallat, 87109
- Pfizer Investigational Site
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Albuquerque, New Mexico, Yhdysvallat, 87108
- Pfizer Investigational Site
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New York
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Mineola, New York, Yhdysvallat, 11501
- Pfizer Investigational Site
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New Hyde Park, New York, Yhdysvallat, 11042
- Pfizer Investigational Site
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Rochester, New York, Yhdysvallat, 14609
- Pfizer Investigational Site
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North Carolina
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Durham, North Carolina, Yhdysvallat, 27713
- Pfizer Investigational Site
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Winston-Salem, North Carolina, Yhdysvallat, 27103
- Pfizer Investigational Site
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Ohio
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Mansfield, Ohio, Yhdysvallat, 44903
- Pfizer Investigational Site
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Oklahoma
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Tulsa, Oklahoma, Yhdysvallat, 74104
- Pfizer Investigational Site
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Rhode Island
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Warwick, Rhode Island, Yhdysvallat, 02886
- Pfizer Investigational Site
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Texas
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Beaumont, Texas, Yhdysvallat, 77701
- Pfizer Investigational Site
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Beaumont, Texas, Yhdysvallat, 77706
- Pfizer Investigational Site
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Corpus Christi, Texas, Yhdysvallat, 78412
- Pfizer Investigational Site
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Corpus Christi, Texas, Yhdysvallat, 78411
- Pfizer Investigational Site
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Dallas, Texas, Yhdysvallat, 75231
- Pfizer Investigational Site
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Dallas, Texas, Yhdysvallat, 75230
- Pfizer Investigational Site
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Dallas, Texas, Yhdysvallat, 75246
- Pfizer Investigational Site
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Houston, Texas, Yhdysvallat, 77079
- Pfizer Investigational Site
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Irving, Texas, Yhdysvallat, 75061
- Pfizer Investigational Site
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San Antonio, Texas, Yhdysvallat, 78229
- Pfizer Investigational Site
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Vermont
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Burlington, Vermont, Yhdysvallat, 05401
- Pfizer Investigational Site
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Virginia
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Richmond, Virginia, Yhdysvallat, 23225
- Pfizer Investigational Site
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Washington
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Renton, Washington, Yhdysvallat, 98055
- Pfizer Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, Yhdysvallat, 53209
- Pfizer Investigational Site
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Type 2 diabetes mellitus
Exclusion Criteria:
- COPD
- Asthma
- Smoking Pregnancy
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Inhaled Insulin
Inhalable short-acting insulin
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Inhaled insulin with dose adjusted according to premeal blood glucose
Muut nimet:
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Active Comparator: Subcutaneous insulin
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Subcutaneous insulin with dose adjusted according to premeal blood glucose
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)
Aikaikkuna: Month 3 through extension Month 60
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Change from Month 3: mean of (value of observed FEV1 [forced expiratory volume in the first second of forced exhalation] in liters [L] at treatment observation minus Month 3 value).
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Month 3 through extension Month 60
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Change From Baseline in FEV1
Aikaikkuna: Baseline through extension follow up Month 3
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Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value).
|
Baseline through extension follow up Month 3
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Annual Rate of Change in FEV1
Aikaikkuna: Week -2 through extension follow up Month 3 or end of study
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Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).
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Week -2 through extension follow up Month 3 or end of study
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Summary of ≥ 15 % Decliners in FEV1
Aikaikkuna: Month 3 through extension follow up Month 3
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Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed.
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Month 3 through extension follow up Month 3
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Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)
Aikaikkuna: Week -2 through extension follow up Month 3 or end of study
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Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr).
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Week -2 through extension follow up Month 3 or end of study
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Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Aikaikkuna: Baseline through extension follow up Month 3
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Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value).
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Baseline through extension follow up Month 3
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Summary of ≥ 20 % Decliners in DLco
Aikaikkuna: Month 3 through extension follow up Month 3
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Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed.
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Month 3 through extension follow up Month 3
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Forced Vital Capacity (FVC)
Aikaikkuna: Week -3 through extension follow up Month 3 or end of study
|
Forced Vital Capacity (FVC) measured in liters (L).
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Week -3 through extension follow up Month 3 or end of study
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Total Lung Capacity (TLC)
Aikaikkuna: Baseline through extension follow up Month 3
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Total Lung Capacity measured in liters (L).
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Baseline through extension follow up Month 3
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Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Aikaikkuna: Baseline through extension follow up Month 3
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Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value).
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Baseline through extension follow up Month 3
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Change From Baseline in Fasting Plasma Glucose (FPG)
Aikaikkuna: Baseline through extension follow up Month 3
|
Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value).
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Baseline through extension follow up Month 3
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Change From Baseline in Body Weight
Aikaikkuna: Baseline through extension follow up Month 3
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Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value).
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Baseline through extension follow up Month 3
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Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Aikaikkuna: Month 3 through extension Month 36
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Total daily long-acting insulin dose unadjusted for body weight.
Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.
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Month 3 through extension Month 36
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Total Daily Long-acting Insulin (Adjusted for Body Weight)
Aikaikkuna: Month 3 through extension Month 36
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Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]).
Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.
|
Month 3 through extension Month 36
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Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Aikaikkuna: Month 3 through extension Month 36
|
Total daily dose of short-acting insulin unadjusted for body weight.
Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin.
|
Month 3 through extension Month 36
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Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Aikaikkuna: Month 3 through extension Month 36
|
Total daily dose of short-acting insulin adjusted for body weight.
Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg).
|
Month 3 through extension Month 36
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Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides
Aikaikkuna: Week -4 through Month 24
|
Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL).
|
Week -4 through Month 24
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Hypoglycemic Event Rates
Aikaikkuna: Month 1 through extension Month 36
|
Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms.
Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval).
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Month 1 through extension Month 36
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Severe Hypoglycemic Event Rates
Aikaikkuna: Month 1 through extension Month 36
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Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose.
Crude event rate: total events divided by subject months multiplied by 100 ([total events/subject months]*100).
Subjects months: elapsed number of months subject was in study in each time interval.
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Month 1 through extension Month 36
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Cough Questionnaire
Aikaikkuna: Week 0 and if indicated through extension follow up Month 3
|
Clinician administered 6 question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (SC or inhaled), and productivity of cough; range 0 (indicates no symptoms) to 4 (indicates severe symptoms).
Questionnaire administered at Week 0 then if and only if, cough is identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.
|
Week 0 and if indicated through extension follow up Month 3
|
Baseline Dyspnea Index (BDI)
Aikaikkuna: Week -1
|
Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort.
BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12).
Lower score indicates greater impairment.
|
Week -1
|
Transition Dyspnea Index (TDI)
Aikaikkuna: Week 4 through extension follow up Month 3 or end of study
|
Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort.
TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration.
Compared to previous scoring to determine deterioration or improvement.
|
Week 4 through extension follow up Month 3 or end of study
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High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
Aikaikkuna: Baseline, M12, M24, Ext M6, Ext M18, Ext M36
|
Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline.
|
Baseline, M12, M24, Ext M6, Ext M18, Ext M36
|
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Aikaikkuna: Baseline, M12, M24, Ext M6, Ext M18, Ext M36
|
Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline.
"No" response at observation further categorized as no significant change (NSC), more abnormal (> Abn), or less abnormal (< Abn).
|
Baseline, M12, M24, Ext M6, Ext M18, Ext M36
|
Insulin Antibodies
Aikaikkuna: Baseline through extension Month 36
|
Observed values for insulin antibodies measured as micro units per milliliter (microU/mL).
|
Baseline through extension Month 36
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Rosenstock J, Cefalu WT, Hollander PA, Klioze SS, Reis J, Duggan WT. Safety and efficacy of inhaled human insulin (exubera) during discontinuation and readministration of therapy in adults with type 2 diabetes: a 3-year randomized controlled trial. Diabetes Technol Ther. 2009 Nov;11(11):697-705. doi: 10.1089/dia.2009.0062.
- Rosenstock J, Cefalu WT, Hollander PA, Belanger A, Eliaschewitz FG, Gross JL, Klioze SS, St Aubin LB, Foyt H, Ogawa M, Duggan WT. Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes. Diabetes Care. 2008 Sep;31(9):1723-8. doi: 10.2337/dc08-0159. Epub 2008 Jun 5.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- A2171029
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