- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00356109
Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes
A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus
A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus.
This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes.
The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Buenos Aires, Argentina, C1213AAH
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Aalst, Belgia, 9300
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Brussels, Belgia, 1070
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Edegem, Belgia, 2650
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Gent, Belgia, 9000
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Leuven, Belgia, 3000
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Colorado
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Aurora, Colorado, Forente stater, 80045
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Florida
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Miami, Florida, Forente stater, 33136
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Georgia
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Atlanta, Georgia, Forente stater, 30309
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Idaho
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Idaho Falls, Idaho, Forente stater, 83404
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Illinois
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Springfield, Illinois, Forente stater, 62704
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Indiana
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Indianapolis, Indiana, Forente stater, 46250
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Maryland
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Baltimore, Maryland, Forente stater, 21204
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Michigan
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Grand Rapids, Michigan, Forente stater, 49503
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New York
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New York, New York, Forente stater, 10025
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
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Texas
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Dallas, Texas, Forente stater, 75246
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El Paso, Texas, Forente stater, 79935
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San Antonio, Texas, Forente stater, 78229
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Utah
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Ogden, Utah, Forente stater, 84403
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Angers, Frankrike, 49033
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Paris, Frankrike, 75475
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Poitiers, Frankrike, 86000
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Toulouse, Frankrike, 31054
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Tours, Frankrike, 37044
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Bangalore, India, 560 054
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Chennai, India, 600 013
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Cochin, India, 682026
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Mumbai, India, 400 007
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New Delhi, India, 110 029
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Milano, Italia, 20142
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Perugia, Italia, 06100
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Guadalajara, Mexico, 44340
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Mexico City, Mexico, 06726
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Toa Baja, Puerto Rico, 00950
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Aschaffenburg, Tyskland, 63739
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Münster, Tyskland, 48145
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Type 1 diabetes for at least 24 months
- Have an HbA1c less than or equal to 11%
- Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
- Non-smoker
Exclusion Criteria:
- Require a daily total insulin dosage greater than 150 U at screening
- Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
- Systemic glucocorticoid therapy
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis
- History of lung transplantation and/or lung cancer
- Diagnosed with pneumonia in the 3 months prior to screening
- History of renal transplantation
- Active or untreated malignancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
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patient specific dose, inhaled, before meals, 6 months
Andre navn:
patient specific dose, injectable, before meals, 6 months
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Aktiv komparator: 2
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patient specific dose, injectable, before meals, 6 months
patient specific dose, injected, before meals, 6 months
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.
Tidsramme: 6 months
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6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Insulin dose requirements
Tidsramme: throughout the study
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throughout the study
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Insulin antibody binding levels
Tidsramme: baseline, 1 month, 6 months, follow-up
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baseline, 1 month, 6 months, follow-up
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To compare HbAlc change
Tidsramme: 6 months
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6 months
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To assess rate and incidence of hypoglycemia
Tidsramme: 6 months
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6 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 9627
- H7U-MC-IDAV
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