A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus
NCT ID: NCT00630825
Last Updated: 2014-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
262 participants
INTERVENTIONAL
2008-04-30
2009-01-31
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
TRIPLE
Study Groups
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1.0/2.0 milligram (mg) LY2189265
LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
LY2189265
1.0/1.0 milligram (mg) LY2189265
LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks
LY2189265
0.5/1.0 milligram (mg) LY2189265
LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
LY2189265
Placebo
Placebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks
Placebo
Interventions
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LY2189265
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men or women 18 years of age or older. Women must have a negative pregnancy test and be willing to use birth control during study duration and one month post.
* Have glycosylated hemoglobin (HbA1c) of \>7.0% to ≤10.5% as determined by central laboratory at screening.
* Have a body mass index (BMI) between 27 and 40 kilograms/meter squared (kg/m\^2), inclusive.
* Have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. Chlorpropamide or Diabinese, Glimepiride or Amaryl, Tolbutamide or Orinase, Tolazamide or Tolinase, Glipizide or Glucotrol, Glyburide also known as Micronase, Diabeta, or Glynase), biguanides (e.g. Glucophage or metformin), thiazolidinediones (e.g. Rosiglitazone or Avandia, or Pioglitazone or Actos), or dipeptidyl peptidase 4 (DPP-IV) inhibitors (e.g. Sitagliptin or Januvia). A combination pill of any 2 of these drugs is allowed (1 only), (e.g. Metformin and Glipizide or Metaglip), (e.g. Metformin and Glyburide or Glucovance), (e.g. Pioglitazone and Glimepiride or Duetact), or (e.g. Sitagliptin and Metformin or Janumet).
Exclusion Criteria
* Have taken glucagon-like peptide-1 (GLP-1) or any GLP-1 analog drug (Byetta)
* Have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty \[PTCA\], open heart surgery, or coronary artery bypass graft \[CABG\]), a transient ischemic attack (TIA) or stroke (cerebrovascular accident) in the last 6 months prior to screening.
* Have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. Have renal disease or a serum creatinine (blood test) \>2 milligrams per deciliter (mg/dL). If taking biguanides (e.g. metformin or Glucophage), or DPP-IV inhibitors (e.g. Sitagliptin or Januvia or Janumet), creatinine must be ≤1.5 mg/dL.
* Currently taking prescription or over the counter medications to prevent weight loss.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Peoria, Arizona, United States
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Anaheim, California, United States
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Lancaster, California, United States
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Northridge, California, United States
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Palm Springs, California, United States
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South Miami, Florida, United States
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West Palm Beach, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Biddeford, Maine, United States
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Ann Arbor, Michigan, United States
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Bloomfield Hills, Michigan, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Flemington, New Jersey, United States
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Syracuse, New York, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Morehead City, North Carolina, 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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Norfolk, Virginia, United States
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Renton, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Wenatchee, Washington, United States
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Menomonee Falls, Wisconsin, United States
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Manatí, , Puerto Rico
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San Juan, , Puerto Rico
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Toa Baja, , Puerto Rico
Countries
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Other Identifiers
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H9X-MC-GBCJ
Identifier Type: OTHER
Identifier Source: secondary_id
12068
Identifier Type: -
Identifier Source: org_study_id