Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
6. september 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
415
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Fortaleza, Brasilien, 60120-020
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Porto Alegre, Brasilien, 90035-003
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São Paulo, Brasilien, 04020041
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California
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Sacramento, California, Forenede Stater, 95825
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Santa Ana, California, Forenede Stater, 92705
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Florida
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Jacksonville, Florida, Forenede Stater, 32204
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Miami, Florida, Forenede Stater, 33156
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70808
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New Jersey
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Hamilton, New Jersey, Forenede Stater, 08610
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29605
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Utah
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Ogden, Utah, Forenede Stater, 84403
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West Virginia
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Charleston, West Virginia, Forenede Stater, 25304
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Bangalore, Indien, 560010
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Mumbai, Indien, 400 007
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Pune, Indien, 411005
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Catania, Italien, 95100
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Genova, Italien, 16132
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Milano, Italien, 20132
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Pisa, Italien, 56100
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Rome, Italien, 00168
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Mexico City, Mexico, 06700
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Monterrey, Mexico, 64410
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Katowice, Polen, 40-044
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Lublin, Polen, 20-954
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Olesnica, Polen
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Coimbra, Portugal, 3000-076
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Lisbon, Portugal, 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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Changhua, Taiwan, 500
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Neihu Taipei, Taiwan, 114
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Yungkang City, Taiwan, 710
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Berlin, Tyskland, 10115
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Dresden, Tyskland, 01307
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Erlangen, Tyskland, 91054
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Frankfurt, Tyskland, 60596
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Leipzig, Tyskland, D-04103
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Mainz, Tyskland, D-55116
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Budapest, Ungarn, H-1139
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Mako, Ungarn, 6900
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Veszprem, Ungarn, 8200
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Zalaegerszeg, Ungarn, 8900
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 1
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patient specific dose, inhaled, before meals, 24 months
Andre navne:
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Aktiv komparator: 2
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patient specific dose, injectable, before meals, 24 months
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
Tidsramme: 6 months
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6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 months
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24 months
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To test dose titration methods
Tidsramme: 6 months
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6 months
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To assess inhaler reliability
Tidsramme: 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
Tidsramme: 3 months, 6 months
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3 months, 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2006
Primær færdiggørelse (Faktiske)
1. maj 2008
Studieafslutning (Faktiske)
1. maj 2008
Datoer for studieregistrering
Først indsendt
10. maj 2006
Først indsendt, der opfyldte QC-kriterier
10. maj 2006
Først opslået (Skøn)
12. maj 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9626
- H7U-MC-IDAU (Anden identifikator: Eli Lilly and Company)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .