- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- 3. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Buenos Aires, Argentína, 1012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vienna, Ausztria, 1090
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Wien, Ausztria, A-1030
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Brugge, Belgium, 8000
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Brussels, Belgium, 1070
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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California
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Santa Ana, California, Egyesült Államok, 92705
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District of Columbia
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Washington, District of Columbia, Egyesült Államok, 20010
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Florida
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Hollywood, Florida, Egyesült Államok, 33021
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New Port Richey, Florida, Egyesült Államok, 34652
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South Miami, Florida, Egyesült Államok, 33143
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Hawaii
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Honolulu, Hawaii, Egyesült Államok, 96813
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Idaho
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Idaho Falls, Idaho, Egyesült Államok, 83404
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Louisiana
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New Orleans, Louisiana, Egyesült Államok, 70121
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Maine
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Biddeford, Maine, Egyesült Államok, 04005
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Minnesota
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Minneapolis, Minnesota, Egyesült Államok, 55416
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New Jersey
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Stratford, New Jersey, Egyesült Államok, 08084
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South Carolina
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Greenville, South Carolina, Egyesült Államok, 29605
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Texas
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Austin, Texas, Egyesült Államok, 78731
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San Antonio, Texas, Egyesült Államok, 78229
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Utah
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Salt Lake City, Utah, Egyesült Államok, 84124
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Washington
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Renton, Washington, Egyesült Államok, 98057
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Tacoma, Washington, Egyesült Államok, 98405
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La Roche Sur Yon, Franciaország, 85925
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La Rochelle, Franciaország, 17019
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Rouen, Franciaország, 76031
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Valenciennes, Franciaország, 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, Mexikó, 44670
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Monterrey, Mexikó, 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, Spanyolország, 46600
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Alicante, Spanyolország, 03114
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Granada, Spanyolország, 18014
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La Coruña, Spanyolország, 15006
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Palma De Mallorca, Spanyolország, 07198
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Requena, Spanyolország, 46340
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: 1
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patient specific dose, inhaled, before meals,6 months
Más nevek:
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Kísérleti: 2
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patient specific dose, inhaled, before meals, 6 months
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
---|---|
Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.
Időkeret: 6 months
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6 months
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Másodlagos eredményintézkedések
Eredménymérő |
Időkeret |
---|---|
A kezeléssel való elégedettség
Időkeret: 6 hónap
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6 hónap
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Mean change in HbA1c from baseline to various endpoints.
Időkeret: 6 months
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6 months
|
Patient safety
Időkeret: throughout the study
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throughout the study
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Patient reported outcome from W-BQ12
Időkeret: screening,baseline,month 6
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screening,baseline,month 6
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Insulin dose
Időkeret: throughout the study
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throughout the study
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Patient reported outcome from DSC-R
Időkeret: screening,baseline, month 6
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screening,baseline, month 6
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Patient reported outcome from DTSQS
Időkeret: screening,baseline, month 6
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screening,baseline, month 6
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Patient reported outcome from IDSQ
Időkeret: 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"
Időkeret: baseline, screening, month 6
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baseline, screening, month 6
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Együttműködők és nyomozók
Szponzor
Együttműködők
Publikációk és hasznos linkek
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 9630
- H7U-MC-IDAY (Egyéb azonosító: Eli Lilly and Company)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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Merck Sharp & Dohme LLCBefejezve2-es típusú diabetes mellitus (T2DM)
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Meir Medical CenterBefejezve2-es típusú diabetes mellitus | Diabetes mellitus, nem inzulinfüggő | Diabetes mellitus, az orális hipoglikémiás kezelésről | Felnőtt típusú diabetes mellitusIzrael