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 almost five months for each participant.
Interventions
DRUGLY3209590
Administered SC.
DRUGInsulin Degludec
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Have type 2 diabetes mellitus (T2DM) for at least 1 year * Have received a stable daily dose of basal insulin at screening * Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening * Have a body mass index greater than (\>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening
Exclusion criteria
* Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg) of body weight at screening * Have received insulins except for basal insulins * Have received sulfonylurea at more than half of the maximum approved dose level * Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy * Have had more than 1 episode of severe hypoglycemia within 6 months before entry
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 85 | 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): Area Under the Drug-Plasma-Concentration-Versus-Time Curve from Time Zero to 168 Hours Postdose (AUC[0-168]) of LY3209590 | Predose on Day 1 through Day 85 | PK: AUC(0-168) of LY3209590 |
| Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose | Day 1 through Day 85 | PD: Change from Baseline in Fasting Plasma Glucose |
Countries
Japan
Outcome results
None listed