Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
6. září 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
415
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Fortaleza, Brazílie, 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, Brazílie, 90035-003
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São Paulo, Brazílie, 04020041
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Bangalore, Indie, 560010
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Mumbai, Indie, 400 007
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Pune, Indie, 411005
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Catania, Itálie, 95100
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Genova, Itálie, 16132
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Milano, Itálie, 20132
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Pisa, Itálie, 56100
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Rome, Itálie, 00168
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Budapest, Maďarsko, H-1139
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Mako, Maďarsko, 6900
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Veszprem, Maďarsko, 8200
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Zalaegerszeg, Maďarsko, 8900
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Mexico City, Mexiko, 06700
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Monterrey, Mexiko, 64410
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Berlin, Německo, 10115
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Dresden, Německo, 01307
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Erlangen, Německo, 91054
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Frankfurt, Německo, 60596
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Leipzig, Německo, D-04103
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Mainz, Německo, D-55116
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Katowice, Polsko, 40-044
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Lublin, Polsko, 20-954
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Olesnica, Polsko
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Manatí, Portoriko, 00674
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San Juan, Portoriko, 00907
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Yabucoa, Portoriko, 00767
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Coimbra, Portugalsko, 3000-076
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Lisbon, Portugalsko, 1250-203
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California
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Sacramento, California, Spojené státy, 95825
- 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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Santa Ana, California, Spojené státy, 92705
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Florida
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Jacksonville, Florida, Spojené státy, 32204
- 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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Miami, Florida, Spojené státy, 33156
- 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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Louisiana
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Baton Rouge, Louisiana, Spojené státy, 70808
- 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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Hamilton, New Jersey, Spojené státy, 08610
- 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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South Carolina
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Greenville, South Carolina, Spojené státy, 29605
- 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, Spojené státy, 84403
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West Virginia
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Charleston, West Virginia, Spojené státy, 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, Tchaj-wan, 500
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Neihu Taipei, Tchaj-wan, 114
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Yungkang City, Tchaj-wan, 710
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 1
|
patient specific dose, inhaled, before meals, 24 months
Ostatní jména:
|
|
Aktivní komparátor: 2
|
patient specific dose, injectable, before meals, 24 months
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
Časové okno: 6 months
|
6 months
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
Časové okno: 24 months
|
24 months
|
|
To compare inhaled human insulin to injectable insulin over time with respect to change on body weight
Časové okno: baseline and every visit
|
baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction
Časové okno: baseline, 6 months, 12 months, 18 months, 24 months
|
baseline, 6 months, 12 months, 18 months, 24 months
|
|
To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c
Časové okno: baseline and every visit
|
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
Časové okno: throughout the study
|
throughout the study
|
|
To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements
Časové okno: 24 months
|
24 months
|
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To test dose titration methods
Časové okno: 6 months
|
6 months
|
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To assess inhaler reliability
Časové okno: throughout the study
|
throughout the study
|
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To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients
Časové okno: 3 months, 6 months
|
3 months, 6 months
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2006
Primární dokončení (Aktuální)
1. května 2008
Dokončení studie (Aktuální)
1. května 2008
Termíny zápisu do studia
První předloženo
10. května 2006
První předloženo, které splnilo kritéria kontroly kvality
10. května 2006
První zveřejněno (Odhad)
12. května 2006
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. září 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. září 2019
Naposledy ověřeno
1. září 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 9626
- H7U-MC-IDAU (Jiný identifikátor: Eli Lilly and Company)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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.
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .