- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00391209
Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus
A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus
This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups:
Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day.
Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Buenos Aires, Argentine, 1012
- 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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Brugge, Belgique, 8000
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Brussels, Belgique, 1070
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Leuven, Belgique, 3000
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Liege, Belgique, 4000
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Alcira, Espagne, 46600
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Alicante, Espagne, 03114
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Granada, Espagne, 18014
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La Coruña, Espagne, 15006
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Palma De Mallorca, Espagne, 07198
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Requena, Espagne, 46340
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La Roche Sur Yon, France, 85925
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La Rochelle, France, 17019
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Rouen, France, 76031
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Valenciennes, France, 59322
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Ahmedabad, Inde, 380006
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Bangalore, Inde, 560052
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Chennai, Inde, 600116
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Vienna, L'Autriche, 1090
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Wien, L'Autriche, A-1030
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Guadalajara, Mexique, 44670
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Monterrey, Mexique, 64060
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Caguas, Porto Rico, 00726
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Ponce, Porto Rico, 00717-2075
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Rio Piedras, Porto Rico, 00921
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California
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Santa Ana, California, États-Unis, 92705
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District of Columbia
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Washington, District of Columbia, États-Unis, 20010
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Florida
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Hollywood, Florida, États-Unis, 33021
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New Port Richey, Florida, États-Unis, 34652
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South Miami, Florida, États-Unis, 33143
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
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Idaho
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Idaho Falls, Idaho, États-Unis, 83404
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Louisiana
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New Orleans, Louisiana, États-Unis, 70121
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Maine
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Biddeford, Maine, États-Unis, 04005
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55416
- 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 Jersey
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Stratford, New Jersey, États-Unis, 08084
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South Carolina
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Greenville, South Carolina, États-Unis, 29605
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Texas
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Austin, Texas, États-Unis, 78731
- 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
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Utah
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Salt Lake City, Utah, États-Unis, 84124
- 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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Washington
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Renton, Washington, États-Unis, 98057
- 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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Tacoma, Washington, États-Unis, 98405
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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 2 diabetes mellitus for at least 6 months
- Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
- Patients who have been treated with the following regimen:
One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones [TZDs]),
AND
have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,
AND
are candidates for insulin therapy, in the opinion of the investigator.
Exclusion Criteria:
- Pregnancy
- Smoker
- History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
- Diagnosed with pneumonia in the 3 months prior to screening
- Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
- History of renal transplantation
- History of lung transplantation
- Active or untreated malignancy
- Treated with Incretin mimetics
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 |
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Expérimental: 1
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patient specific dose, inhaled, before meals,6 months
Autres noms:
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Expérimental: 2
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patient specific dose, inhaled, before meals, 6 months
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.
Délai: 6 months
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Satisfaction du traitement
Délai: 6 mois
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6 mois
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Mean change in HbA1c from baseline to various endpoints.
Délai: 6 months
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6 months
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Patient safety
Délai: throughout the study
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throughout the study
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Patient reported outcome from W-BQ12
Délai: screening,baseline,month 6
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screening,baseline,month 6
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Insulin dose
Délai: throughout the study
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throughout the study
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Patient reported outcome from DSC-R
Délai: screening,baseline, month 6
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screening,baseline, month 6
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Patient reported outcome from DTSQS
Délai: screening,baseline, month 6
|
screening,baseline, month 6
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Patient reported outcome from IDSQ
Délai: Month 1, 2 and 6
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Month 1, 2 and 6
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Patient reported outcome from "Expectations About Insulin Therapy Questionnaire"
Délai: baseline, screening, month 6
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baseline, screening, month 6
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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
- 9630
- H7U-MC-IDAY (Autre identifiant: Eli Lilly and Company)
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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