- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Aschaffenburg, Allemagne, 63739
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Münster, Allemagne, 48145
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Buenos Aires, Argentine, C1213AAH
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Aalst, Belgique, 9300
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Brussels, Belgique, 1070
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Edegem, Belgique, 2650
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Gent, Belgique, 9000
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Leuven, Belgique, 3000
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Angers, France, 49033
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Paris, France, 75475
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Poitiers, France, 86000
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Toulouse, France, 31054
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Tours, France, 37044
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Bangalore, Inde, 560 054
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Chennai, Inde, 600 013
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Cochin, Inde, 682026
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Mumbai, Inde, 400 007
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New Delhi, Inde, 110 029
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Milano, Italie, 20142
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Perugia, Italie, 06100
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Guadalajara, Mexique, 44340
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Mexico City, Mexique, 06726
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Toa Baja, Porto Rico, 00950
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Colorado
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Aurora, Colorado, États-Unis, 80045
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Florida
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Miami, Florida, États-Unis, 33136
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Georgia
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Atlanta, Georgia, États-Unis, 30309
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Idaho
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Idaho Falls, Idaho, États-Unis, 83404
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Illinois
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Springfield, Illinois, États-Unis, 62704
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Indiana
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Indianapolis, Indiana, États-Unis, 46250
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Maryland
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Baltimore, Maryland, États-Unis, 21204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Grand Rapids, Michigan, États-Unis, 49503
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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New York, New York, États-Unis, 10025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Dallas, Texas, États-Unis, 75246
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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El Paso, Texas, États-Unis, 79935
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Antonio, Texas, États-Unis, 78229
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Utah
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Ogden, Utah, États-Unis, 84403
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1
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patient specific dose, inhaled, before meals, 6 months
Autres noms:
patient specific dose, injectable, before meals, 6 months
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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
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.
Délai: 6 months
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Insulin dose requirements
Délai: throughout the study
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throughout the study
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Insulin antibody binding levels
Délai: 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
Délai: 6 months
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6 months
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To assess rate and incidence of hypoglycemia
Délai: 6 months
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6 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 9627
- H7U-MC-IDAV
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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