Diabetes Mellitus, Type 2
Conditions
Brief summary
This study will evaluate the safety and tolerability of LY3209590 when given by injection under the skin to participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects will be documented. This study will last approximately 17 weeks, not including screening. Screening is required within 4 weeks prior to the start of the study.
Interventions
DRUGInsulin Glargine
Administered SC
DRUGLY3209590
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
Yes
Inclusion criteria
* Participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year * Have a glycated hemoglobin (HbA1c) greater than or equal to (≥) 7.0 percent (%) to less than or equal to (≤) 10.5% at screening * Have had no episodes of severe hypoglycemia in the past 6 months * Are on stable basal insulin (neutral protamine Hagedorn insulin suspension \[NPH\] insulin, insulin glargine \[U100 or U300\], or insulin detemir) with or without metformin, dipeptidyl peptidase IV (DPP-IV) inhibitors, sulfonylureas, and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, at a stable dose for at least 3 months before screening
Exclusion criteria
* Have significant lipohypertrophy in the target abdominal injection * Have a history of renal impairment * Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children) * Have proliferative retinopathy or maculopathy and/or severe neuropathy * Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening * Require daily insulin treatment less than (\<) 0.15 unit/kilogram (U/kg) per body weight * Are treated with a continuous subcutaneous insulin infusion (CSII) pump * Currently receiving degludec insulin therapy, or have been treated with degludec within the past 90 days
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 17 weeks | 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 (AUC[0-168]) of LY3209590 | Week 6 | PK: AUC(0-168) of LY3209590 |
| Pharmacodynamics (PD): Average Glucose from 7-Point Glucose Profiles | Baseline, Day 4, Day 40, Day 43 | PD: Average Glucose from 7-Point Glucose Profiles |
Countries
Canada, United States
Outcome results
None listed