Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
12 januari 2011 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
339
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arizona
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Phoenix, Arizona, Förenta staterna, 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, Förenta staterna, 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, Förenta staterna, 92026
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Fresno, California, Förenta staterna, 93720
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Modesto, California, Förenta staterna, 95355
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Orange, California, Förenta staterna, 92869
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Florida
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Inverness, Florida, Förenta staterna, 34452
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Jacksonville, Florida, Förenta staterna, 32204
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Lake Worth, Florida, Förenta staterna, 33461
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Miami, Florida, Förenta staterna, 33183
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Orlando, Florida, Förenta staterna, 32804
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Palm Harbor, Florida, Förenta staterna, 34684
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Pembroke Pines, Florida, Förenta staterna, 33029
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Plantation, Florida, Förenta staterna, 33324
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West Palm Beach, Florida, Förenta staterna, 33401
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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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Indiana
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Avon, Indiana, Förenta staterna, 46123
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Bloomington, Indiana, Förenta staterna, 47403
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South Bend, Indiana, Förenta staterna, 46617
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Iowa
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Des Moines, Iowa, Förenta staterna, 50314
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40503
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70808
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Lafayette, Louisiana, Förenta staterna, 70503
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Metairie, Louisiana, Förenta staterna, 70006
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Maine
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Biddeford, Maine, Förenta staterna, 04005
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Missouri
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Chesterfield, Missouri, Förenta staterna, 63017
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Jefferson City, Missouri, Förenta staterna, 65109
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St Louis, Missouri, Förenta staterna, 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, Förenta staterna, 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, Förenta staterna, 89148
- 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 Hampshire
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Nashua, New Hampshire, Förenta staterna, 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, Förenta staterna, 14607
- 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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Syracuse, New York, Förenta staterna, 13210
- 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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North Carolina
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Morehead City, North Carolina, Förenta staterna, 28557
- 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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Ohio
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London, Ohio, Förenta staterna, 43140
- 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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Mason, Ohio, Förenta staterna, 45040
- 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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Toledo, Ohio, Förenta staterna, 43606
- 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 Carolina
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Greer, South Carolina, Förenta staterna, 29651
- 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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Myrtle Beach, South Carolina, Förenta staterna, 29572
- 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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Tennessee
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Kingsport, Tennessee, Förenta staterna, 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, Förenta staterna, 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, Förenta staterna, 78731
- 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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Dallas, Texas, Förenta staterna, 75231
- 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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San Antonio, Texas, Förenta staterna, 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, Förenta staterna, 05403
- 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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Virginia
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Virginia Beach, Virginia, Förenta staterna, 23462
- 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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Washington
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Spokane, Washington, Förenta staterna, 99202
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Vancouver, Washington, Förenta staterna, 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 74 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: ILPS
Insulin Lispro Protamine Suspension (ILPS)
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Administered subcutaneously once a day at bedtime
Andra namn:
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Aktiv komparator: Glargine
Insulin Glargine
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Administered subcutaneously once a day at bedtime
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
Tidsram: Baseline, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
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Baseline, Endpoint (LOCF) up to 24 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Tidsram: 24 weeks, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
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24 weeks, Endpoint (LOCF) up to 24 weeks
|
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Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Tidsram: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
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Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
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Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Tidsram: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
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Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
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7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Tidsram: Baseline, Endpoint (LOCF) up to 24 weeks
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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.
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Baseline, Endpoint (LOCF) up to 24 weeks
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Glycemic Variability at Baseline and Endpoint (LOCF)
Tidsram: Baseline, Endpoint (LOCF) up to 24 weeks
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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.
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Baseline, Endpoint (LOCF) up to 24 weeks
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Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Tidsram: 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.
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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)
Tidsram: 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.
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Baseline to Endpoint (LOCF) up to 24 weeks
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Actual Body Weight at Baseline and Endpoint (LOCF)
Tidsram: Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
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Change From Baseline in Body Weight at Endpoint (LOCF)
Tidsram: Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
|
Total Daily Insulin Dose at Endpoint (LOCF)
Tidsram: Endpoint (LOCF) up to 24 weeks
|
Endpoint (LOCF) up to 24 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2007
Primärt slutförande (Faktisk)
1 december 2009
Avslutad studie (Faktisk)
1 december 2009
Studieregistreringsdatum
Först inskickad
15 november 2007
Först inskickad som uppfyllde QC-kriterierna
15 november 2007
Första postat (Uppskatta)
19 november 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 januari 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 januari 2011
Senast verifierad
1 januari 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Störningar i glukosmetabolism
- Metaboliska sjukdomar
- Sjukdomar i det endokrina systemet
- Diabetes mellitus
- Diabetes mellitus, typ 2
- Hypoglykemiska medel
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Koagulanter
- Heparinantagonister
- Insulin
- Insulin, Globin Zink
- Insulin Glargine
- Insulin Lispro
- Protaminer
Andra studie-ID-nummer
- 11647
- F3Z-US-IOPB (Annan identifierare: Eli Lilly and Company)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .