MedPath

I8F-JE-GPGC

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Registration Number
JPRN-jRCT2080223709
Lead Sponsor
Eli Lilly Japan K.K.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
completed
Sex
All
Target Recruitment
49
Inclusion Criteria

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 Criteria

- Have known allergies to LY3298176, 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
safety<br>Adverse events
Secondary Outcome Measures
NameTimeMethod
pharmacokinetics<br>pharmacodynamics<br>AUC, Cmax, Fasting plasma glucose levels
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