Type 2 Diabetes Mellitus
Conditions
Keywords
Insulin
Brief summary
The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days.
Interventions
DRUGLY3209590
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participants with Type 2 Diabetes Mellitus (T2DM) for at least 3 months * Have Glycated hemoglobin (HbA1c) level of 6.5 percent (%) to 9.5% at screening * Have a body mass index equal to or less than 45.0 kilograms per square meter (kg/m²) * Participants are insulin naïve or have been without insulin treatment for at least 3 months prior to screening
Exclusion criteria
* Have had a severe hypoglycemia in the past 6 months * Have a history of renal impairment * Have had a blood transfusion or severe blood loss within last 90 days * Have had a significant weight gain or loss of approximately 6% or more within 3 months prior to screening. * Have a history of an active or untreated malignancy * Are receiving or received systemic glucocorticoid therapy * Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590 | Predose up to 65 days post dose |
| PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590 | Predose up to 65 days post dose |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Fasting Glucose | Baseline, 65 days |
Countries
United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed