Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
3. Februar 2010 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
582
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Buenos Aires
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Capital Federal, Buenos Aires, Argentinien, C1120 AAF
- Pfizer Investigational Site
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Capital Federal, Buenos Aires, Argentinien, C1181 ACH
- Pfizer Investigational Site
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Capital Federal, Buenos Aires, Argentinien, C1405 DCS
- Pfizer Investigational Site
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Capital Federal, Buenos Aires, Argentinien, C1427 AQR
- Pfizer Investigational Site
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MG
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Belo Horizonte, MG, Brasilien, 30150-221
- Pfizer Investigational Site
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PR
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Curitiba, PR, Brasilien, 80420-011
- Pfizer Investigational Site
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RS
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Porto Alegre, RS, Brasilien, 90035-170
- Pfizer Investigational Site
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Porto Alegre, RS, Brasilien, 90035-903
- Pfizer Investigational Site
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SP
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Campinas, SP, Brasilien, 13083-900
- Pfizer Investigational Site
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Sao Paulo, SP, Brasilien, 01244-030
- Pfizer Investigational Site
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Sao Paulo, SP, Brasilien, 04231-030
- Pfizer Investigational Site
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São Paulo, SP, Brasilien, 04020-041
- 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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Edmonton, Alberta, Kanada, T5J 3N4
- Pfizer Investigational Site
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Edmonton, Alberta, Kanada, T6G 2C8
- 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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Kingston, Ontario, Kanada, K7L 2V7
- Pfizer Investigational Site
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London, Ontario, Kanada, N6A 4V2
- Pfizer Investigational Site
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Mississauga, Ontario, Kanada, L5M 2V8
- Pfizer Investigational Site
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Oakville, Ontario, Kanada, L6H 3P1
- Pfizer Investigational Site
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Ottawa, Ontario, Kanada, K1H 1A2
- Pfizer Investigational Site
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Thornhill, Ontario, Kanada, L4J 8L7
- Pfizer Investigational Site
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Toronto, Ontario, Kanada, M4R 2G4
- 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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Sherbrooke, Quebec, Kanada, J1H 5N4
- Pfizer Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7N 0W8
- Pfizer Investigational Site
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Col Las Americas
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Mexico Df, Col Las Americas, Mexiko, 01120
- Pfizer Investigational Site
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DF
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Mexico, DF, Mexiko, 14000
- Pfizer Investigational Site
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Mexico, DF, Mexiko, 02990
- Pfizer Investigational Site
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexiko, 64060
- Pfizer Investigational Site
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California
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Fullerton, California, Vereinigte Staaten, 92835
- Pfizer Investigational Site
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Long Beach, California, Vereinigte Staaten, 90806
- Pfizer Investigational Site
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Sacramento, California, Vereinigte Staaten, 95816
- Pfizer Investigational Site
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San Diego, California, Vereinigte Staaten, 92103
- Pfizer Investigational Site
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Santa Barbara, California, Vereinigte Staaten, 93105
- Pfizer Investigational Site
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Santa Rosa, California, Vereinigte Staaten, 95405
- Pfizer Investigational Site
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Tustin, California, Vereinigte Staaten, 92780
- Pfizer Investigational Site
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Walnut Creek, California, Vereinigte Staaten, 94598
- Pfizer Investigational Site
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80220
- Pfizer Investigational Site
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Longmont, Colorado, Vereinigte Staaten, 80501
- Pfizer Investigational Site
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Connecticut
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Hamden, Connecticut, Vereinigte Staaten, 06518
- Pfizer Investigational Site
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Madison, Connecticut, Vereinigte Staaten, 06443
- Pfizer Investigational Site
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Delaware
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Newark, Delaware, Vereinigte Staaten, 19713
- Pfizer Investigational Site
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Florida
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Coral Gables, Florida, Vereinigte Staaten, 33134
- Pfizer Investigational Site
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Hollywood, Florida, Vereinigte Staaten, 33021
- Pfizer Investigational Site
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Miami, Florida, Vereinigte Staaten, 33136
- Pfizer Investigational Site
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Tallahassee, Florida, Vereinigte Staaten, 32308
- Pfizer Investigational Site
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West Palm Beach, Florida, Vereinigte Staaten, 33401
- Pfizer Investigational Site
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Winter Park, Florida, Vereinigte Staaten, 32789
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60610
- Pfizer Investigational Site
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Chicago, Illinois, Vereinigte Staaten, 60602
- Pfizer Investigational Site
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Wilmette, Illinois, Vereinigte Staaten, 60091
- Pfizer Investigational Site
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Maryland
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Bethesda, Maryland, Vereinigte Staaten, 20817
- Pfizer Investigational Site
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Missouri
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St. Louis, Missouri, Vereinigte Staaten, 63141
- Pfizer Investigational Site
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Montana
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Butte, Montana, Vereinigte Staaten, 59701
- Pfizer Investigational Site
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New York
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New Hyde Park, New York, Vereinigte Staaten, 11042
- Pfizer Investigational Site
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27713
- Pfizer Investigational Site
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97210
- Pfizer Investigational Site
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Pennsylvania
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Lansdale, Pennsylvania, Vereinigte Staaten, 19446
- Pfizer Investigational Site
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Texas
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Dallas, Texas, Vereinigte Staaten, 75230
- Pfizer Investigational Site
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Dallas, Texas, Vereinigte Staaten, 75246
- Pfizer Investigational Site
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San Antonio, Texas, Vereinigte Staaten, 78229
- Pfizer Investigational Site
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Vermont
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Burlington, Vermont, Vereinigte Staaten, 05401
- Pfizer Investigational Site
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Virginia
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Richmond, Virginia, Vereinigte Staaten, 23225
- Pfizer Investigational Site
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Washington
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Renton, Washington, Vereinigte Staaten, 98057
- Pfizer Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, Vereinigte Staaten, 53209
- Pfizer Investigational Site
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Type 1 diabetes mellitus
Exclusion Criteria:
- severe asthma or COPD
- smoking
- brittle diabetes
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Subkutanes Insulin
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Subcutaneous insulin with dose adjusted according to premeal blood glucose
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Experimental: Inhaliertes Insulin
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Inhaled insulin with dose adjusted according to premeal blood glucose
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Zeitfenster: Baseline through Extension Follow-up Month 3
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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).
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Baseline through Extension Follow-up Month 3
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Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Zeitfenster: Month 3 through Extension Follow-up 3
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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.
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Month 3 through Extension Follow-up 3
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Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Zeitfenster: Baseline through Extension Follow-up Month 3
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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).
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Baseline through Extension Follow-up Month 3
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Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Zeitfenster: Month 3 through Extension Follow-up Month 3
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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.
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Month 3 through Extension Follow-up Month 3
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Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1)
Zeitfenster: Week -2 through Extension Follow-up Month 6 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 6 or end of study
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Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)
Zeitfenster: Week -2 through Extension Follow-up Month 6 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 hemoglobin per year (ml/min/mmHg/yr).
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Week -2 through Extension Follow-up Month 6 or end of study
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Zeitfenster: Baseline through Extension Follow-up Month 3
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Change from Baseline: mean of (value of Glycosylated Hemoglobin [HbA1c] at observation minus Baseline value).
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Baseline through Extension Follow-up Month 3
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Hypoglycemic Event Rates
Zeitfenster: Month 1 through Extension Month 39
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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.
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Month 1 through Extension Month 39
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Severe Hypoglycemic Event Rates
Zeitfenster: Month 1 through Extension Month 39
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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.
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Month 1 through Extension Month 39
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Change From Baseline in Fasting Plasma Glucose
Zeitfenster: Baseline through Extension Follow-up Month 3
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Change from Baseline: mean of (value of fasting plasma glucose [milligrams per deciliter (mg/dL)] at observation minus Baseline value).
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Baseline through Extension Follow-up Month 3
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Change From Baseline Body Weight
Zeitfenster: Baseline through Extension Follow-up Month 3
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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.
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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)
Zeitfenster: Month 3 through Extension Month 39
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Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight; long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.
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Month 3 through Extension Month 39
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Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Zeitfenster: Month 3 through Extension Month 39
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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.
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Month 3 through Extension Month 39
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Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Zeitfenster: Month 3 through Extension Month 39
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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.
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Month 3 through Extension Month 39
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Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Zeitfenster: Month 3 through Extension Month 39
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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.
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Month 3 through Extension Month 39
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Baseline Dyspnea Index (BDI)
Zeitfenster: Week - 1
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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.
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Week - 1
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Transition Dyspnea Index (TDI)
Zeitfenster: Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study
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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.
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Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study
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Lipids
Zeitfenster: Week -4 through Month 24
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Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides measured as milligrams per deciliter (mg/dL).
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Week -4 through Month 24
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Cough Questionnaire
Zeitfenster: 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.
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Week 0 and if indicated through Extension Follow up Month 3
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Forced Vital Capacity (FVC)
Zeitfenster: Week -3 through Extension Follow-up Month 6 or End of Study
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Forced Vital Capacity (FVC) measured in liters (L).
|
Week -3 through Extension Follow-up Month 6 or End of Study
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Total Lung Capacity (TLC)
Zeitfenster: Week -3 through Extension Follow-up Month 6 or End of Study
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Total Lung Capacity measured in liters (L).
|
Week -3 through Extension Follow-up Month 6 or End of Study
|
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Insulin Antibodies
Zeitfenster: Baseline through Extension Month 39
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Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL).
|
Baseline through Extension Month 39
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Mai 2002
Primärer Abschluss (Tatsächlich)
1. Dezember 2008
Studienabschluss (Tatsächlich)
1. Dezember 2008
Studienanmeldedaten
Zuerst eingereicht
26. August 2005
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. August 2005
Zuerst gepostet (Schätzen)
29. August 2005
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
18. Februar 2010
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Februar 2010
Zuletzt verifiziert
1. Dezember 2009
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- A2171022
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