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

3. februar 2010 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

582

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  • severe asthma or COPD
  • smoking
  • brittle diabetes

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Subkutan insulin
Medicin: Subcutaneous Insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose
Eksperimentel: Inhaleret insulin
Medicin: Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline through Extension Month 39
Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL).
Baseline through Extension Month 39

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2002

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. december 2008

Datoer for studieregistrering

Først indsendt

26. august 2005

Først indsendt, der opfyldte QC-kriterier

26. august 2005

Først opslået (Skøn)

29. august 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. februar 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. februar 2010

Sidst verificeret

1. december 2009

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A2171022

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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