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

3. února 2010 aktualizováno: 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.

Přehled studie

Postavení

Ukončeno

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

582

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Type 1 diabetes mellitus

Exclusion Criteria:

  • severe asthma or COPD
  • smoking
  • brittle diabetes

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Subkutánní inzulín
Lék: Subcutaneous Insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose
Experimentální: Inhalační inzulín
Lék: Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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).
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: Baseline through Extension Month 39
Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL).
Baseline through Extension Month 39

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2002

Primární dokončení (Aktuální)

1. prosince 2008

Dokončení studie (Aktuální)

1. prosince 2008

Termíny zápisu do studia

První předloženo

26. srpna 2005

První předloženo, které splnilo kritéria kontroly kvality

26. srpna 2005

První zveřejněno (Odhad)

29. srpna 2005

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

18. února 2010

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. února 2010

Naposledy ověřeno

1. prosince 2009

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • A2171022

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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