Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
6 września 2019 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
415
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Fortaleza, Brazylia, 60120-020
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Porto Alegre, Brazylia, 90035-003
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São Paulo, Brazylia, 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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Mexico City, Meksyk, 06700
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Monterrey, Meksyk, 64410
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Berlin, Niemcy, 10115
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Dresden, Niemcy, 01307
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Erlangen, Niemcy, 91054
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Frankfurt, Niemcy, 60596
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Leipzig, Niemcy, D-04103
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Mainz, Niemcy, D-55116
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Katowice, Polska, 40-044
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Lublin, Polska, 20-954
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Olesnica, Polska
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Manatí, Portoryko, 00674
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San Juan, Portoryko, 00907
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Yabucoa, Portoryko, 00767
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Coimbra, Portugalia, 3000-076
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Lisbon, Portugalia, 1250-203
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California
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Sacramento, California, Stany Zjednoczone, 95825
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Santa Ana, California, Stany Zjednoczone, 92705
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Florida
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Jacksonville, Florida, Stany Zjednoczone, 32204
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Miami, Florida, Stany Zjednoczone, 33156
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Louisiana
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Baton Rouge, Louisiana, Stany Zjednoczone, 70808
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New Jersey
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Hamilton, New Jersey, Stany Zjednoczone, 08610
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South Carolina
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Greenville, South Carolina, Stany Zjednoczone, 29605
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Utah
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Ogden, Utah, Stany Zjednoczone, 84403
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West Virginia
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Charleston, West Virginia, Stany Zjednoczone, 25304
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Changhua, Tajwan, 500
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Neihu Taipei, Tajwan, 114
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Yungkang City, Tajwan, 710
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Budapest, Węgry, H-1139
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Mako, Węgry, 6900
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Veszprem, Węgry, 8200
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Zalaegerszeg, Węgry, 8900
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Catania, Włochy, 95100
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Genova, Włochy, 16132
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Milano, Włochy, 20132
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Pisa, Włochy, 56100
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Rome, Włochy, 00168
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 1
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patient specific dose, inhaled, before meals, 24 months
Inne nazwy:
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Aktywny komparator: 2
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patient specific dose, injectable, before meals, 24 months
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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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
Ramy czasowe: 6 months
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6 months
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 24 months
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24 months
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To test dose titration methods
Ramy czasowe: 6 months
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6 months
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To assess inhaler reliability
Ramy czasowe: 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
Ramy czasowe: 3 months, 6 months
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3 months, 6 months
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 kwietnia 2006
Zakończenie podstawowe (Rzeczywisty)
1 maja 2008
Ukończenie studiów (Rzeczywisty)
1 maja 2008
Daty rejestracji na studia
Pierwszy przesłany
10 maja 2006
Pierwszy przesłany, który spełnia kryteria kontroli jakości
10 maja 2006
Pierwszy wysłany (Oszacować)
12 maja 2006
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
16 września 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 września 2019
Ostatnia weryfikacja
1 września 2019
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 9626
- H7U-MC-IDAU (Inny identyfikator: Eli Lilly and Company)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Ramy czasowe udostępniania 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.
Kryteria dostępu do udostępniania IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- CSR
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .