- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Buenos Aires, Argentina, 1012
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Brugge, Belgien, 8000
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Brussels, Belgien, 1070
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Leuven, Belgien, 3000
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Liege, Belgien, 4000
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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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California
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Santa Ana, California, Förenta staterna, 92705
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20010
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Florida
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Hollywood, Florida, Förenta staterna, 33021
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New Port Richey, Florida, Förenta staterna, 34652
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South Miami, Florida, Förenta staterna, 33143
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
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Idaho
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Idaho Falls, Idaho, Förenta staterna, 83404
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70121
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Maine
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Biddeford, Maine, Förenta staterna, 04005
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55416
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New Jersey
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Stratford, New Jersey, Förenta staterna, 08084
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29605
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Texas
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Austin, Texas, Förenta staterna, 78731
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San Antonio, Texas, Förenta staterna, 78229
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Utah
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Salt Lake City, Utah, Förenta staterna, 84124
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Washington
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Renton, Washington, Förenta staterna, 98057
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Tacoma, Washington, Förenta staterna, 98405
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Ahmedabad, Indien, 380006
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Bangalore, Indien, 560052
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Chennai, Indien, 600116
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Guadalajara, Mexiko, 44670
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Monterrey, Mexiko, 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, Spanien, 46600
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Alicante, Spanien, 03114
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Granada, Spanien, 18014
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La Coruña, Spanien, 15006
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Palma De Mallorca, Spanien, 07198
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Requena, Spanien, 46340
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Vienna, Österrike, 1090
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Wien, Österrike, A-1030
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
|
Läkemedel: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals,6 months
Andra namn:
|
Experimentell: 2
|
patient specific dose, inhaled, before meals, 6 months
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.
Tidsram: 6 months
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6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Behandlingstillfredsställelse
Tidsram: 6 månader
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6 månader
|
Mean change in HbA1c from baseline to various endpoints.
Tidsram: 6 months
|
6 months
|
Patient safety
Tidsram: throughout the study
|
throughout the study
|
Patient reported outcome from W-BQ12
Tidsram: screening,baseline,month 6
|
screening,baseline,month 6
|
Insulin dose
Tidsram: throughout the study
|
throughout the study
|
Patient reported outcome from DSC-R
Tidsram: screening,baseline, month 6
|
screening,baseline, month 6
|
Patient reported outcome from DTSQS
Tidsram: screening,baseline, month 6
|
screening,baseline, month 6
|
Patient reported outcome from IDSQ
Tidsram: Month 1, 2 and 6
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Month 1, 2 and 6
|
Patient reported outcome from "Expectations About Insulin Therapy Questionnaire"
Tidsram: baseline, screening, month 6
|
baseline, screening, month 6
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 9630
- H7U-MC-IDAY (Annan identifierare: Eli Lilly and Company)
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