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 Chinese participants with type 2 diabetes mellitus who are on a stable dose of basal insulin. Side effects and tolerability will be documented. Blood samples will be taken to assess how the body processes the study drug and the effect of the study drug on blood sugar levels. The study will last up to 18 weeks and may include 18 visits for each participant.
Interventions
DRUGLY3209590
Administered SC.
DRUGInsulin Glargine
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
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) and treated with basal insulin and up to one non-insulin anti-hyperglycemic medication. * Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²) * 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 * Native Chinese participant who has both parents and all 4 grandparents of Chinese origin.
Exclusion criteria
* Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes * Have a history of ketoacidosis or hyperosmolar state/coma episode or severe hypoglycemia or hypoglycemia unawareness in the 6 months prior to screening * Are receiving insulin other than once daily basal insulin * Have any active infectious or serious disease or major organs insufficiency * Women who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to Week 12 | Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration |
| Incidence and Severity of Hypoglycemia | Baseline up to Week 12 | Incidence and Severity of Hypoglycemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose | Baseline through Week 6 | PD: Change from Baseline in Fasting Plasma Glucose |
| PD: Change from Baseline in 7-Point Glucose | Baseline through Week 6 | PD: Change from Baseline in 7-Point Glucose |
Countries
China
Outcome results
None listed