Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
2011. január 12. frissítette: Eli Lilly and Company
A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide
This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
339
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Arizona
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Phoenix, Arizona, Egyesült Államok, 85028
- 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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California
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Concord, California, Egyesült Államok, 94520
- 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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Escondido, California, Egyesült Államok, 92026
- 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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Fresno, California, Egyesült Államok, 93720
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Modesto, California, Egyesült Államok, 95355
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Orange, California, Egyesült Államok, 92869
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Florida
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Inverness, Florida, Egyesült Államok, 34452
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Jacksonville, Florida, Egyesült Államok, 32204
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Lake Worth, Florida, Egyesült Államok, 33461
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Miami, Florida, Egyesült Államok, 33183
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Orlando, Florida, Egyesült Államok, 32804
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Palm Harbor, Florida, Egyesült Államok, 34684
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Pembroke Pines, Florida, Egyesült Államok, 33029
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Plantation, Florida, Egyesült Államok, 33324
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West Palm Beach, Florida, Egyesült Államok, 33401
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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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Indiana
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Avon, Indiana, Egyesült Államok, 46123
- 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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Bloomington, Indiana, Egyesült Államok, 47403
- 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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South Bend, Indiana, Egyesült Államok, 46617
- 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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Iowa
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Des Moines, Iowa, Egyesült Államok, 50314
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Kentucky
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Lexington, Kentucky, Egyesült Államok, 40503
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Louisiana
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Baton Rouge, Louisiana, Egyesült Államok, 70808
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Lafayette, Louisiana, Egyesült Államok, 70503
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Metairie, Louisiana, Egyesült Államok, 70006
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Maine
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Biddeford, Maine, Egyesült Államok, 04005
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Missouri
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Chesterfield, Missouri, Egyesült Államok, 63017
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Jefferson City, Missouri, Egyesült Államok, 65109
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St Louis, Missouri, Egyesült Államok, 63104
- 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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Nebraska
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Omaha, Nebraska, Egyesült Államok, 68131
- 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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Nevada
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Las Vegas, Nevada, Egyesült Államok, 89148
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New Hampshire
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Nashua, New Hampshire, Egyesült Államok, 03063
- 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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New York
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Rochester, New York, Egyesült Államok, 14607
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Syracuse, New York, Egyesült Államok, 13210
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North Carolina
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Morehead City, North Carolina, Egyesült Államok, 28557
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Ohio
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London, Ohio, Egyesült Államok, 43140
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Mason, Ohio, Egyesült Államok, 45040
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Toledo, Ohio, Egyesült Államok, 43606
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South Carolina
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Greer, South Carolina, Egyesült Államok, 29651
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Myrtle Beach, South Carolina, Egyesült Államok, 29572
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Tennessee
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Kingsport, Tennessee, Egyesült Államok, 37660
- 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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Memphis, Tennessee, Egyesült Államok, 38119
- 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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Texas
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Austin, Texas, Egyesült Államok, 78731
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Dallas, Texas, Egyesült Államok, 75231
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San Antonio, Texas, Egyesült Államok, 78229
- 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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Vermont
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South Burlington, Vermont, Egyesült Államok, 05403
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Virginia
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Virginia Beach, Virginia, Egyesült Államok, 23462
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Washington
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Spokane, Washington, Egyesült Államok, 99202
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Vancouver, Washington, Egyesült Államok, 98664
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Ponce, Puerto Rico, 00731
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Toa Baja, Puerto Rico, 00949
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Yabucoa, Puerto Rico, 00767
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
Inclusion Criteria:
- Must have type 2 diabetes
- Must be at least 18 years of age and less than 75 years of age
- Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
- Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
- Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%
Exclusion Criteria:
- Must not have used insulin on a regular basis during the past 2 years
- Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
- Must not have had more than one episode of severe hypoglycemia in the past 6 months
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
- Must not be pregnant or intend to get pregnant during the course of the study
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
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 |
|---|---|
|
Aktív összehasonlító: ILPS
Insulin Lispro Protamine Suspension (ILPS)
|
Administered subcutaneously once a day at bedtime
Más nevek:
|
|
Aktív összehasonlító: Glargine
Insulin Glargine
|
Administered subcutaneously once a day at bedtime
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
Időkeret: Baseline, Endpoint (LOCF) up to 24 weeks
|
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Időkeret: 24 weeks, Endpoint (LOCF) up to 24 weeks
|
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
|
24 weeks, Endpoint (LOCF) up to 24 weeks
|
|
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Időkeret: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
|
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
|
Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
|
|
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Időkeret: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
|
Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
|
|
|
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Időkeret: Baseline, Endpoint (LOCF) up to 24 weeks
|
SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours.
Post-prandial glucose is measured 2 hours after the start of the meal.
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
Glycemic Variability at Baseline and Endpoint (LOCF)
Időkeret: Baseline, Endpoint (LOCF) up to 24 weeks
|
Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose.
Mean SD was calculated based on the SD for each participant in the study.
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Időkeret: Baseline to Endpoint (LOCF) up to 24 weeks
|
Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL.
Non-nocturnal:any episode that occurred between waking and bedtime.
Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.
|
Baseline to Endpoint (LOCF) up to 24 weeks
|
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Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Időkeret: Baseline to Endpoint (LOCF) up to 24 weeks
|
Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall.
Rate is reported as episodes/participant/365 days.
Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment.
Overall=any time during the post-randomization visits within the study period.
Nocturnal=Any episode that occurs between bedtime and waking.
Non-Nocturnal=Any episode that occurs between waking and bedtime.
|
Baseline to Endpoint (LOCF) up to 24 weeks
|
|
Actual Body Weight at Baseline and Endpoint (LOCF)
Időkeret: Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
|
Change From Baseline in Body Weight at Endpoint (LOCF)
Időkeret: Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
|
Total Daily Insulin Dose at Endpoint (LOCF)
Időkeret: Endpoint (LOCF) up to 24 weeks
|
Endpoint (LOCF) up to 24 weeks
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2007. november 1.
Elsődleges befejezés (Tényleges)
2009. december 1.
A tanulmány befejezése (Tényleges)
2009. december 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2007. november 15.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2007. november 15.
Első közzététel (Becslés)
2007. november 19.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2011. január 13.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2011. január 12.
Utolsó ellenőrzés
2011. január 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Glükóz anyagcserezavarok
- Anyagcsere-betegségek
- Endokrin rendszer betegségei
- Diabetes mellitus
- Cukorbetegség, 2-es típusú
- Hipoglikémiás szerek
- A gyógyszerek élettani hatásai
- A farmakológiai hatás molekuláris mechanizmusai
- Koagulánsok
- Heparin antagonisták
- Inzulin
- Inzulin, Globin Cink
- Glargine inzulin
- Lispro inzulin
- Protaminok
Egyéb vizsgálati azonosító számok
- 11647
- F3Z-US-IOPB (Egyéb azonosító: Eli Lilly and Company)
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