A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
NCT ID: NCT01468181
Last Updated: 2015-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
394 participants
INTERVENTIONAL
2011-11-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LY2189265 + Sulfonylureas (SU)
LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
LY2189265
Sulfonylureas (SU)
SU is a pre-study prescribed dose and is not being provided as part of the trial.
LY2189265 + Biguanides (BG)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
LY2189265
Biguanides (BG)
Biguanides is a pre-study prescribed dose and is not being provided as part of the trial.
LY2189265 + alpha-glucosidase inhibitor (a-GI)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
LY2189265
alpha-glucosidase inhibitor (a-GI)
a-GI is a pre-study prescribed dose and is not being provided as part of the trial.
LY2189265 + Thiazolidinedione (TZD)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
LY2189265
Thiazolidinedione (TZD)
TZD is a pre-study prescribed dose and is not being provided as part of the trial.
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
LY2189265
Glinides
Glinides is a pre-study prescribed dose and is not being provided as part of the trial.
Interventions
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LY2189265
Sulfonylureas (SU)
SU is a pre-study prescribed dose and is not being provided as part of the trial.
Biguanides (BG)
Biguanides is a pre-study prescribed dose and is not being provided as part of the trial.
alpha-glucosidase inhibitor (a-GI)
a-GI is a pre-study prescribed dose and is not being provided as part of the trial.
Thiazolidinedione (TZD)
TZD is a pre-study prescribed dose and is not being provided as part of the trial.
Glinides
Glinides is a pre-study prescribed dose and is not being provided as part of the trial.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening
* Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening
* Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2)
Exclusion Criteria
* Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog within the 3 months before screening
* Participants who are currently taking insulin or have had previous insulin treatment within the 3 months before screening
* Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening
* Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)
20 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) or 1-317-615-4559 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.
Aichi, , Japan
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.
Chiba, , Japan
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.
Hokkaido, , Japan
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.
Hyōgo, , Japan
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.
Ibaraki, , Japan
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.
Kanagawa, , Japan
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.
Kyoto, , Japan
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.
Nagano, , Japan
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.
Okayama, , Japan
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.
Osaka, , Japan
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.
Saitama, , Japan
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.
Tokyo, , Japan
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.
Toyama, , Japan
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.
Wakayama, , Japan
Countries
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Other Identifiers
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H9X-JE-GBDQ
Identifier Type: OTHER
Identifier Source: secondary_id
13991
Identifier Type: -
Identifier Source: org_study_id
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