A Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients with Type 2 Diabetes Mellitus
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT2080223988
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:
1. Have T2DM diagnosed at least 1 year
2. Have hemoglobin A1c (HbA1c) >=7.0% and <=10.0% with Fasting Plasma Glucose (FPG) of >=126 mg/dL, or HbA1c >=6.5% and <7.0% with FPG of >=144 mg/dL, at screening
3. Have a body weight of >=54 kg, and a body mass index of >18.5 and <=40.0 kg/m2 at screening
Exclusion Criteria:
1. Have received a total daily dose of insulin >1.2 U/kg at screening
2. Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening
3. Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction.
4. Have a history of heart block, or a repeated demonstration of abnormality in the 12-lead ECG at screening, in the opinion of the investigator, increases the risks associated with participating in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method