Status:
COMPLETED
A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- Have type 2 diabetes (based on the World Health Organization \[WHO\] diagnostic criteria) for at least 1 year.
- 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
- Have known allergies to dulaglutide, or other glucagon-like peptide-1 (GLP-1) receptor agonists.
- 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.
Key Trial Info
Start Date :
October 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03315780
Start Date
October 28 2017
End Date
February 28 2018
Last Update
September 16 2019
Active Locations (1)
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1
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, 812-0025