Diabetes Mellitus, Type 2
Conditions
Brief summary
The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.
Interventions
DRUGLY3209590
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Cohort 3 is open-label.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have T2DM diagnosed at least 1 year ago * Have hemoglobin A1c (HbA1c) ≥7.0% and ≤10.0% with fasting plasma glucose (FPG) ≥126 milligrams per deciliter (mg/dL) or HbA1c ≥6.5% and \<7.0% with FPG ≥144 mg/dL at screening * Have body weight ≥54 kilograms and a body mass index \>18.5 and ≤40.0 kilograms per square meter at screening
Exclusion criteria
* Have received a total daily dose of insulin \>1.2 units per kilogram at screening * Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening * Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction * Have a history of heart block or a repeated demonstration of abnormality in the 12-lead electrocardiogram at screening, which in the opinion of the investigator, increases the risks associated with participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 28 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3209590 | Baseline through Day 28 | PK: Cmax of LY3209590 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3209590 | Baseline through Day 28 | PK: AUC of LY3209590 |
| Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose | Baseline through Day 15 | PD: Change from Baseline in Fasting Plasma Glucose |
Countries
Japan
Outcome results
None listed