A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes
NCT ID: NCT03315780
Last Updated: 2019-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2017-10-28
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Dulaglutide, Placebo
Dulaglutide 0.75 mg administered subcutaneously (SC) once weekly for 4 weeks in period 1 followed by placebo administered SC once weekly for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2.
Dulaglutide
Administered SC
Placebo
Administered SC
Placebo, Dulaglutide
Placebo administered SC once weekly for 4 weeks in Period 1 followed by Dulaglutide 0.75 mg administered SC for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2.
Dulaglutide
Administered SC
Placebo
Administered SC
Interventions
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Dulaglutide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have diet and exercise therapy only (no oral antihyperglycemic medication for at least 3 months prior to screening).
* Have a fasting blood glucose value of ≥120 and ≤200 milligrams per deciliter (mg/dL) at screening.
* Have a screening body weight of ≥50 and ≤80 kilograms.
Exclusion Criteria
* Have had a clinically significant cardiovascular disease.
* Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery.
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease.
* Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis.
* Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 meter squared.
* In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
20 Years
75 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 9 AM - 5 PM 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.
Fukuoka, , Japan
Countries
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References
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Inoue M, Shiramoto M, Oura T, Nasu R, Nakano M, Takeuchi M. Effect of Once-Weekly Dulaglutide on Glucose Levels in Japanese Patients with Type 2 Diabetes: Findings from a Phase 4, Randomized Controlled Trial. Diabetes Ther. 2019 Jun;10(3):1019-1027. doi: 10.1007/s13300-019-0605-7. Epub 2019 Apr 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H9X-JE-GBGK
Identifier Type: OTHER
Identifier Source: secondary_id
16730
Identifier Type: -
Identifier Source: org_study_id
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