- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00391209
Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus
A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus
This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups:
Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day.
Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Buenos Aires, Argentina, 1012
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Brugge, Belgia, 8000
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Brussels, Belgia, 1070
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Leuven, Belgia, 3000
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Liege, Belgia, 4000
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California
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Santa Ana, California, Forente stater, 92705
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District of Columbia
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Washington, District of Columbia, Forente stater, 20010
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Florida
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Hollywood, Florida, Forente stater, 33021
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New Port Richey, Florida, Forente stater, 34652
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South Miami, Florida, Forente stater, 33143
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Hawaii
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Honolulu, Hawaii, Forente stater, 96813
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Idaho
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Idaho Falls, Idaho, Forente stater, 83404
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Louisiana
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New Orleans, Louisiana, Forente stater, 70121
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Maine
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Biddeford, Maine, Forente stater, 04005
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55416
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New Jersey
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Stratford, New Jersey, Forente stater, 08084
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
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Texas
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Austin, Texas, Forente stater, 78731
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San Antonio, Texas, Forente stater, 78229
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Utah
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Salt Lake City, Utah, Forente stater, 84124
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Washington
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Renton, Washington, Forente stater, 98057
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Tacoma, Washington, Forente stater, 98405
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La Roche Sur Yon, Frankrike, 85925
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La Rochelle, Frankrike, 17019
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Rouen, Frankrike, 76031
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Valenciennes, Frankrike, 59322
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Ahmedabad, India, 380006
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Bangalore, India, 560052
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Chennai, India, 600116
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Guadalajara, Mexico, 44670
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Monterrey, Mexico, 64060
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Caguas, Puerto Rico, 00726
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Ponce, Puerto Rico, 00717-2075
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Rio Piedras, Puerto Rico, 00921
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Alcira, Spania, 46600
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Alicante, Spania, 03114
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Granada, Spania, 18014
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La Coruña, Spania, 15006
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Palma De Mallorca, Spania, 07198
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Requena, Spania, 46340
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Vienna, Østerrike, 1090
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Wien, Østerrike, A-1030
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes mellitus for at least 6 months
- Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
- Patients who have been treated with the following regimen:
One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones [TZDs]),
AND
have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,
AND
are candidates for insulin therapy, in the opinion of the investigator.
Exclusion Criteria:
- Pregnancy
- Smoker
- History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
- Diagnosed with pneumonia in the 3 months prior to screening
- Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
- History of renal transplantation
- History of lung transplantation
- Active or untreated malignancy
- Treated with Incretin mimetics
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
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patient specific dose, inhaled, before meals,6 months
Andre navn:
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Eksperimentell: 2
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patient specific dose, inhaled, before meals, 6 months
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.
Tidsramme: 6 months
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6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Behandlingstilfredshet
Tidsramme: 6 måneder
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6 måneder
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Mean change in HbA1c from baseline to various endpoints.
Tidsramme: 6 months
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6 months
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Patient safety
Tidsramme: throughout the study
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throughout the study
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Patient reported outcome from W-BQ12
Tidsramme: screening,baseline,month 6
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screening,baseline,month 6
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Insulin dose
Tidsramme: throughout the study
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throughout the study
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Patient reported outcome from DSC-R
Tidsramme: screening,baseline, month 6
|
screening,baseline, month 6
|
Patient reported outcome from DTSQS
Tidsramme: screening,baseline, month 6
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screening,baseline, month 6
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Patient reported outcome from IDSQ
Tidsramme: Month 1, 2 and 6
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Month 1, 2 and 6
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Patient reported outcome from "Expectations About Insulin Therapy Questionnaire"
Tidsramme: baseline, screening, month 6
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baseline, screening, month 6
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 9630
- H7U-MC-IDAY (Annen identifikator: Eli Lilly and Company)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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