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Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

3 lutego 2010 zaktualizowane przez: Pfizer

Efficacy and Safety of Exubera (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 1 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 a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171022 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

582

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentyna, C1120 AAF
        • Pfizer Investigational Site
      • Capital Federal, Buenos Aires, Argentyna, C1181 ACH
        • Pfizer Investigational Site
      • Capital Federal, Buenos Aires, Argentyna, C1405 DCS
        • Pfizer Investigational Site
      • Capital Federal, Buenos Aires, Argentyna, C1427 AQR
        • Pfizer Investigational Site
  • Brazylia
    • MG
      • Belo Horizonte, MG, Brazylia, 30150-221
        • Pfizer Investigational Site
    • PR
      • Curitiba, PR, Brazylia, 80420-011
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazylia, 90035-170
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brazylia, 90035-903
        • Pfizer Investigational Site
    • SP
      • Campinas, SP, Brazylia, 13083-900
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazylia, 01244-030
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazylia, 04231-030
        • Pfizer Investigational Site
      • São Paulo, SP, Brazylia, 04020-041
        • Pfizer Investigational Site
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2T 5C7
        • Pfizer Investigational Site
      • Calgary, Alberta, Kanada, T3B 0M3
        • Pfizer Investigational Site
      • Edmonton, Alberta, Kanada, T5J 3N4
        • Pfizer Investigational Site
      • Edmonton, Alberta, Kanada, T6G 2C8
        • Pfizer Investigational Site
    • British Columbia
      • Victoria, British Columbia, Kanada, V8R 1J8
        • Pfizer Investigational Site
    • Manitoba
      • Winnepeg, Manitoba, Kanada, R3A 1R9
        • Pfizer Investigational Site
      • Winnipeg, Manitoba, Kanada, R3E 3P4
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3H 1V7
        • Pfizer Investigational Site
      • Halifax, Nova Scotia, Kanada, B3H 2Y9
        • Pfizer Investigational Site
    • Ontario
      • Kingston, Ontario, Kanada, K7L 2V7
        • Pfizer Investigational Site
      • London, Ontario, Kanada, N6A 4V2
        • Pfizer Investigational Site
      • Mississauga, Ontario, Kanada, L5M 2V8
        • Pfizer Investigational Site
      • Oakville, Ontario, Kanada, L6H 3P1
        • Pfizer Investigational Site
      • Ottawa, Ontario, Kanada, K1H 1A2
        • Pfizer Investigational Site
      • Thornhill, Ontario, Kanada, L4J 8L7
        • Pfizer Investigational Site
      • Toronto, Ontario, Kanada, M4R 2G4
        • Pfizer Investigational Site
    • Quebec
      • Laval, Quebec, Kanada, H7T 2P5
        • Pfizer Investigational Site
      • Montreal, Quebec, Kanada, H3A 1A1
        • Pfizer Investigational Site
      • Montreal, Quebec, Kanada, H1T 2M4
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Kanada, J1H 5N4
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7N 0W8
        • Pfizer Investigational Site
  • Meksyk
    • Col Las Americas
      • Mexico Df, Col Las Americas, Meksyk, 01120
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Meksyk, 14000
        • Pfizer Investigational Site
      • Mexico, DF, Meksyk, 02990
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Meksyk, 64060
        • Pfizer Investigational Site
  • Stany Zjednoczone
    • California
      • Fullerton, California, Stany Zjednoczone, 92835
        • Pfizer Investigational Site
      • Long Beach, California, Stany Zjednoczone, 90806
        • Pfizer Investigational Site
      • Sacramento, California, Stany Zjednoczone, 95816
        • Pfizer Investigational Site
      • San Diego, California, Stany Zjednoczone, 92103
        • Pfizer Investigational Site
      • Santa Barbara, California, Stany Zjednoczone, 93105
        • Pfizer Investigational Site
      • Santa Rosa, California, Stany Zjednoczone, 95405
        • Pfizer Investigational Site
      • Tustin, California, Stany Zjednoczone, 92780
        • Pfizer Investigational Site
      • Walnut Creek, California, Stany Zjednoczone, 94598
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, Stany Zjednoczone, 80220
        • Pfizer Investigational Site
      • Longmont, Colorado, Stany Zjednoczone, 80501
        • Pfizer Investigational Site
    • Connecticut
      • Hamden, Connecticut, Stany Zjednoczone, 06518
        • Pfizer Investigational Site
      • Madison, Connecticut, Stany Zjednoczone, 06443
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, Stany Zjednoczone, 19713
        • Pfizer Investigational Site
    • Florida
      • Coral Gables, Florida, Stany Zjednoczone, 33134
        • Pfizer Investigational Site
      • Hollywood, Florida, Stany Zjednoczone, 33021
        • Pfizer Investigational Site
      • Miami, Florida, Stany Zjednoczone, 33136
        • Pfizer Investigational Site
      • Tallahassee, Florida, Stany Zjednoczone, 32308
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Stany Zjednoczone, 33401
        • Pfizer Investigational Site
      • Winter Park, Florida, Stany Zjednoczone, 32789
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60610
        • Pfizer Investigational Site
      • Chicago, Illinois, Stany Zjednoczone, 60602
        • Pfizer Investigational Site
      • Wilmette, Illinois, Stany Zjednoczone, 60091
        • Pfizer Investigational Site
    • Maryland
      • Bethesda, Maryland, Stany Zjednoczone, 20817
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, Stany Zjednoczone, 63141
        • Pfizer Investigational Site
    • Montana
      • Butte, Montana, Stany Zjednoczone, 59701
        • Pfizer Investigational Site
    • New York
      • New Hyde Park, New York, Stany Zjednoczone, 11042
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, Stany Zjednoczone, 27713
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97210
        • Pfizer Investigational Site
    • Pennsylvania
      • Lansdale, Pennsylvania, Stany Zjednoczone, 19446
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, Stany Zjednoczone, 75246
        • Pfizer Investigational Site
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, Stany Zjednoczone, 05401
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, Stany Zjednoczone, 23225
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, Stany Zjednoczone, 98057
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Stany Zjednoczone, 53209
        • Pfizer Investigational Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  • severe asthma or COPD
  • smoking
  • brittle diabetes

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Insulina podskórna
Lek: Subcutaneous Insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose
Eksperymentalny: Insulina wziewna
Lek: Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Ramy czasowe: Baseline through Extension Follow-up Month 3
Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value).
Baseline through Extension Follow-up Month 3
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Ramy czasowe: Month 3 through Extension Follow-up 3
Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed.
Month 3 through Extension Follow-up 3
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Ramy czasowe: Baseline through Extension Follow-up Month 3
Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity [DLco] measured in milliters/minutes/millimeters of mercury [mL/min/mmHg] at observation minus Baseline value).
Baseline through Extension Follow-up Month 3
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Ramy czasowe: Month 3 through Extension Follow-up Month 3
Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat DLco was performed.
Month 3 through Extension Follow-up Month 3
Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1)
Ramy czasowe: Week -2 through Extension Follow-up Month 6 or end of study
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).
Week -2 through Extension Follow-up Month 6 or end of study
Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)
Ramy czasowe: Week -2 through Extension Follow-up Month 6 or end of study
Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of hemoglobin per year (ml/min/mmHg/yr).
Week -2 through Extension Follow-up Month 6 or end of study

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Ramy czasowe: Baseline through Extension Follow-up Month 3
Change from Baseline: mean of (value of Glycosylated Hemoglobin [HbA1c] at observation minus Baseline value).
Baseline through Extension Follow-up Month 3
Hypoglycemic Event Rates
Ramy czasowe: Month 1 through Extension Month 39
A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Subject months = elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject month of treatment.
Month 1 through Extension Month 39
Severe Hypoglycemic Event Rates
Ramy czasowe: Month 1 through Extension Month 39
Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); and blood glucose measurement was ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Subject months = elapsed number of months subject was in study in each time interval. Crude event rate = total events divided by subject months * 100.
Month 1 through Extension Month 39
Change From Baseline in Fasting Plasma Glucose
Ramy czasowe: Baseline through Extension Follow-up Month 3
Change from Baseline: mean of (value of fasting plasma glucose [milligrams per deciliter (mg/dL)] at observation minus Baseline value).
Baseline through Extension Follow-up Month 3
Change From Baseline Body Weight
Ramy czasowe: Baseline through Extension Follow-up Month 3
Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus mean baseline body weight.
Baseline through Extension Follow-up Month 3
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Ramy czasowe: Month 3 through Extension Month 39
Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight; long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.
Month 3 through Extension Month 39
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Ramy czasowe: Month 3 through Extension Month 39
Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.
Month 3 through Extension Month 39
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Ramy czasowe: Month 3 through Extension Month 39
Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.
Month 3 through Extension Month 39
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Ramy czasowe: Month 3 through Extension Month 39
Total Daily Short-Acting Insulin Dose adjusted for body weight (milligrams [mg] or units divided by kilograms [kg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.
Month 3 through Extension Month 39
Baseline Dyspnea Index (BDI)
Ramy czasowe: 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)
Ramy czasowe: Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter 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 6 and every 6 months thereafter or end of study
Lipids
Ramy czasowe: Week -4 through Month 24
Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides measured as milligrams per deciliter (mg/dL).
Week -4 through Month 24
Cough Questionnaire
Ramy czasowe: Week 0 and if indicated through Extension Follow up Month 3
Subject completed cough questionnaire with reference to the past 4 weeks. Six question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (subcutaneous [SC] or inhaled), and productivity of cough; range 0 (no symptoms) to 4 (severe symptoms). Questionnaire was administered at Week 0 and then at subsequent visits only if cough was 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
Forced Vital Capacity (FVC)
Ramy czasowe: Week -3 through Extension Follow-up Month 6 or End of Study
Forced Vital Capacity (FVC) measured in liters (L).
Week -3 through Extension Follow-up Month 6 or End of Study
Total Lung Capacity (TLC)
Ramy czasowe: Week -3 through Extension Follow-up Month 6 or End of Study
Total Lung Capacity measured in liters (L).
Week -3 through Extension Follow-up Month 6 or End of Study
Insulin Antibodies
Ramy czasowe: Baseline through Extension Month 39
Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL).
Baseline through Extension Month 39

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 maja 2002

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2008

Ukończenie studiów (Rzeczywisty)

1 grudnia 2008

Daty rejestracji na studia

Pierwszy przesłany

26 sierpnia 2005

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 sierpnia 2005

Pierwszy wysłany (Oszacować)

29 sierpnia 2005

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

18 lutego 2010

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 lutego 2010

Ostatnia weryfikacja

1 grudnia 2009

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • A2171022

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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