Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
perjantai 6. syyskuuta 2019 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
415
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Fortaleza, Brasilia, 60120-020
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Porto Alegre, Brasilia, 90035-003
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São Paulo, Brasilia, 04020041
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Bangalore, Intia, 560010
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Mumbai, Intia, 400 007
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Pune, Intia, 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, Meksiko, 06700
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Monterrey, Meksiko, 64410
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Coimbra, Portugali, 3000-076
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Lisbon, Portugali, 1250-203
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Manatí, Puerto Rico, 00674
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San Juan, Puerto Rico, 00907
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Yabucoa, Puerto Rico, 00767
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Katowice, Puola, 40-044
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Lublin, Puola, 20-954
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Olesnica, Puola
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Berlin, Saksa, 10115
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Dresden, Saksa, 01307
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Erlangen, Saksa, 91054
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Frankfurt, Saksa, 60596
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Leipzig, Saksa, D-04103
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Mainz, Saksa, D-55116
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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, Unkari, H-1139
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Mako, Unkari, 6900
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Veszprem, Unkari, 8200
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Zalaegerszeg, Unkari, 8900
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California
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Sacramento, California, Yhdysvallat, 95825
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Santa Ana, California, Yhdysvallat, 92705
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Florida
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Jacksonville, Florida, Yhdysvallat, 32204
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Miami, Florida, Yhdysvallat, 33156
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Louisiana
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Baton Rouge, Louisiana, Yhdysvallat, 70808
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New Jersey
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Hamilton, New Jersey, Yhdysvallat, 08610
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South Carolina
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Greenville, South Carolina, Yhdysvallat, 29605
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Utah
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Ogden, Utah, Yhdysvallat, 84403
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West Virginia
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Charleston, West Virginia, Yhdysvallat, 25304
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 1
|
patient specific dose, inhaled, before meals, 24 months
Muut nimet:
|
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Active Comparator: 2
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patient specific dose, injectable, before meals, 24 months
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
Aikaikkuna: 6 months
|
6 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
Aikaikkuna: 24 months
|
24 months
|
|
To compare inhaled human insulin to injectable insulin over time with respect to change on body weight
Aikaikkuna: baseline and every visit
|
baseline and every visit
|
|
To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: throughout the study
|
throughout the study
|
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To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements
Aikaikkuna: 24 months
|
24 months
|
|
To test dose titration methods
Aikaikkuna: 6 months
|
6 months
|
|
To assess inhaler reliability
Aikaikkuna: throughout the study
|
throughout the study
|
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To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients
Aikaikkuna: 3 months, 6 months
|
3 months, 6 months
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Lauantai 1. huhtikuuta 2006
Ensisijainen valmistuminen (Todellinen)
Torstai 1. toukokuuta 2008
Opintojen valmistuminen (Todellinen)
Torstai 1. toukokuuta 2008
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 10. toukokuuta 2006
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 10. toukokuuta 2006
Ensimmäinen Lähetetty (Arvio)
Perjantai 12. toukokuuta 2006
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 16. syyskuuta 2019
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 6. syyskuuta 2019
Viimeksi vahvistettu
Sunnuntai 1. syyskuuta 2019
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 9626
- H7U-MC-IDAU (Muu tunniste: Eli Lilly and Company)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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.
IPD-jaon aikakehys
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.
IPD-jaon käyttöoikeuskriteerit
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- CSR
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .