Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
NCT ID: NCT00560417
Last Updated: 2011-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
339 participants
INTERVENTIONAL
2007-11-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ILPS
Insulin Lispro Protamine Suspension (ILPS)
Insulin Lispro Protamine Suspension
Administered subcutaneously once a day at bedtime
Glargine
Insulin Glargine
Insulin Glargine
Administered subcutaneously once a day at bedtime
Interventions
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Insulin Lispro Protamine Suspension
Administered subcutaneously once a day at bedtime
Insulin Glargine
Administered subcutaneously once a day at bedtime
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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%
* 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
Exclusion Criteria
18 Years
74 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Phoenix, Arizona, United States
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Concord, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Modesto, California, United States
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Orange, California, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Lake Worth, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Pembroke Pines, Florida, United States
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Plantation, Florida, United States
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West Palm Beach, Florida, United States
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Honolulu, Hawaii, United States
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Idaho Falls, Idaho, United States
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Avon, Indiana, United States
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Bloomington, Indiana, United States
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South Bend, Indiana, United States
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Des Moines, Iowa, United States
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Lexington, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Lafayette, Louisiana, United States
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Metairie, Louisiana, United States
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Biddeford, Maine, United States
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Chesterfield, Missouri, United States
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Jefferson City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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Morehead City, North Carolina, United States
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London, Ohio, United States
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Mason, Ohio, United States
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Toledo, Ohio, United States
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Greer, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Kingsport, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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South Burlington, Vermont, United States
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Virginia Beach, Virginia, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Ponce, , Puerto Rico
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Toa Baja, , Puerto Rico
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Yabucoa, , Puerto Rico
Countries
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Other Identifiers
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F3Z-US-IOPB
Identifier Type: OTHER
Identifier Source: secondary_id
11647
Identifier Type: -
Identifier Source: org_study_id
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