Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
6 settembre 2019 aggiornato da: Eli Lilly and Company
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes.
Patients will be treated for 24 months with a 2-month follow-up period.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
415
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Fortaleza, Brasile, 60120-020
- 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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Porto Alegre, Brasile, 90035-003
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São Paulo, Brasile, 04020041
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Berlin, Germania, 10115
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Dresden, Germania, 01307
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Erlangen, Germania, 91054
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Frankfurt, Germania, 60596
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Leipzig, Germania, D-04103
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Mainz, Germania, D-55116
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Bangalore, India, 560010
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Mumbai, India, 400 007
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Pune, India, 411005
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Catania, Italia, 95100
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Genova, Italia, 16132
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Milano, Italia, 20132
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Pisa, Italia, 56100
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Rome, Italia, 00168
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Mexico City, Messico, 06700
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Monterrey, Messico, 64410
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Katowice, Polonia, 40-044
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Lublin, Polonia, 20-954
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Olesnica, Polonia
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Manatí, Porto Rico, 00674
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San Juan, Porto Rico, 00907
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Yabucoa, Porto Rico, 00767
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Coimbra, Portogallo, 3000-076
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Lisbon, Portogallo, 1250-203
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California
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Sacramento, California, Stati Uniti, 95825
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Santa Ana, California, Stati Uniti, 92705
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Florida
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Jacksonville, Florida, Stati Uniti, 32204
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Miami, Florida, Stati Uniti, 33156
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70808
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New Jersey
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Hamilton, New Jersey, Stati Uniti, 08610
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29605
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Utah
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Ogden, Utah, Stati Uniti, 84403
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West Virginia
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Charleston, West Virginia, Stati Uniti, 25304
- 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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Changhua, Taiwan, 500
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Neihu Taipei, Taiwan, 114
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Yungkang City, Taiwan, 710
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Budapest, Ungheria, H-1139
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Mako, Ungheria, 6900
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Veszprem, Ungheria, 8200
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Zalaegerszeg, Ungheria, 8900
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Type 2 diabetes
- Non smoker
- Normal lung function
Exclusion Criteria:
- Pulmonary, hepatic, or renal disease
- Congestive heart failure
- Active malignancy
- Systemic glucocorticoid therapy
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 1
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patient specific dose, inhaled, before meals, 24 months
Altri nomi:
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Comparatore attivo: 2
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patient specific dose, injectable, before meals, 24 months
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
Lasso di tempo: 6 months
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6 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
Lasso di tempo: 24 months
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24 months
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To compare inhaled human insulin to injectable insulin over time with respect to change on body weight
Lasso di tempo: baseline and every visit
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baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction
Lasso di tempo: baseline, 6 months, 12 months, 18 months, 24 months
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baseline, 6 months, 12 months, 18 months, 24 months
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To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c
Lasso di tempo: baseline and every visit
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baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia
Lasso di tempo: throughout the study
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throughout the study
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To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements
Lasso di tempo: 24 months
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24 months
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To test dose titration methods
Lasso di tempo: 6 months
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6 months
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To assess inhaler reliability
Lasso di tempo: throughout the study
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throughout the study
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To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients
Lasso di tempo: 3 months, 6 months
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3 months, 6 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2006
Completamento primario (Effettivo)
1 maggio 2008
Completamento dello studio (Effettivo)
1 maggio 2008
Date di iscrizione allo studio
Primo inviato
10 maggio 2006
Primo inviato che soddisfa i criteri di controllo qualità
10 maggio 2006
Primo Inserito (Stima)
12 maggio 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
16 settembre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 settembre 2019
Ultimo verificato
1 settembre 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 9626
- H7U-MC-IDAU (Altro identificatore: Eli Lilly and Company)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Periodo di condivisione IPD
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
Criteri di accesso alla condivisione IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .