Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

3 febbraio 2010 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

582

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Brasile
    • MG
      • Belo Horizonte, MG, Brasile, 30150-221
        • Pfizer Investigational Site
    • PR
      • Curitiba, PR, Brasile, 80420-011
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brasile, 90035-170
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brasile, 90035-903
        • Pfizer Investigational Site
    • SP
      • Campinas, SP, Brasile, 13083-900
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brasile, 01244-030
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brasile, 04231-030
        • Pfizer Investigational Site
      • São Paulo, SP, Brasile, 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
  • Messico
    • Col Las Americas
      • Mexico Df, Col Las Americas, Messico, 01120
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Messico, 14000
        • Pfizer Investigational Site
      • Mexico, DF, Messico, 02990
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Messico, 64060
        • Pfizer Investigational Site
  • Stati Uniti
    • California
      • Fullerton, California, Stati Uniti, 92835
        • Pfizer Investigational Site
      • Long Beach, California, Stati Uniti, 90806
        • Pfizer Investigational Site
      • Sacramento, California, Stati Uniti, 95816
        • Pfizer Investigational Site
      • San Diego, California, Stati Uniti, 92103
        • Pfizer Investigational Site
      • Santa Barbara, California, Stati Uniti, 93105
        • Pfizer Investigational Site
      • Santa Rosa, California, Stati Uniti, 95405
        • Pfizer Investigational Site
      • Tustin, California, Stati Uniti, 92780
        • Pfizer Investigational Site
      • Walnut Creek, California, Stati Uniti, 94598
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, Stati Uniti, 80220
        • Pfizer Investigational Site
      • Longmont, Colorado, Stati Uniti, 80501
        • Pfizer Investigational Site
    • Connecticut
      • Hamden, Connecticut, Stati Uniti, 06518
        • Pfizer Investigational Site
      • Madison, Connecticut, Stati Uniti, 06443
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, Stati Uniti, 19713
        • Pfizer Investigational Site
    • Florida
      • Coral Gables, Florida, Stati Uniti, 33134
        • Pfizer Investigational Site
      • Hollywood, Florida, Stati Uniti, 33021
        • Pfizer Investigational Site
      • Miami, Florida, Stati Uniti, 33136
        • Pfizer Investigational Site
      • Tallahassee, Florida, Stati Uniti, 32308
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Stati Uniti, 33401
        • Pfizer Investigational Site
      • Winter Park, Florida, Stati Uniti, 32789
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60610
        • Pfizer Investigational Site
      • Chicago, Illinois, Stati Uniti, 60602
        • Pfizer Investigational Site
      • Wilmette, Illinois, Stati Uniti, 60091
        • Pfizer Investigational Site
    • Maryland
      • Bethesda, Maryland, Stati Uniti, 20817
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, Stati Uniti, 63141
        • Pfizer Investigational Site
    • Montana
      • Butte, Montana, Stati Uniti, 59701
        • Pfizer Investigational Site
    • New York
      • New Hyde Park, New York, Stati Uniti, 11042
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27713
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, Stati Uniti, 97210
        • Pfizer Investigational Site
    • Pennsylvania
      • Lansdale, Pennsylvania, Stati Uniti, 19446
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, Stati Uniti, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, Stati Uniti, 75246
        • Pfizer Investigational Site
      • San Antonio, Texas, Stati Uniti, 78229
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, Stati Uniti, 05401
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23225
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, Stati Uniti, 98057
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53209
        • Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  • severe asthma or COPD
  • smoking
  • brittle diabetes

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Insulina sottocutanea
Droga: Subcutaneous Insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose
Sperimentale: Insulina per via inalatoria
Droga: Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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).
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline through Extension Month 39
Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL).
Baseline through Extension Month 39

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2002

Completamento primario (Effettivo)

1 dicembre 2008

Completamento dello studio (Effettivo)

1 dicembre 2008

Date di iscrizione allo studio

Primo inviato

26 agosto 2005

Primo inviato che soddisfa i criteri di controllo qualità

26 agosto 2005

Primo Inserito (Stima)

29 agosto 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 febbraio 2010

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 febbraio 2010

Ultimo verificato

1 dicembre 2009

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A2171022

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi