Status:
COMPLETED
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
Brief Summary
The purposes of this study are to determine: * The safety of tirzepatide and any side effects that might be associated with it. * How much tirzepatide gets into the bloodstream and how long it takes ...
Eligibility Criteria
Inclusion
- Have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin or dipeptidyl peptidase \[DPP\]-IV inhibitors)
- Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive
Exclusion
- Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds
- Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- Have an abnormality in the 12-lead electrocardiogram at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or any GI disease which impacts gastric emptying or could be aggravated by GLP-1 analogs or DPP-IV inhibitors
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03322631
Start Date
November 15 2017
End Date
November 28 2018
Last Update
March 23 2023
Active Locations (2)
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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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Hachiōji, Tokyo, Japan, 192-0071
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Shinjuku-Ku, Tokyo, Japan, 169-0073