Type 2 Diabetes
Conditions
Brief summary
The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.
Interventions
DRUGDulaglutide
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Have Type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening. * Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile
Exclusion criteria
* Have Type 1 diabetes * Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening * After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome * Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) * Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease * Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Week 26 | A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide | Predose through Week 30 |
| PK: Maximum Observed Concentration (Cmax) of Dulaglutide | Predose through Week 30 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 26 |
| Percent Change from Baseline in Body Weight | Baseline, Week 26 |
| Change from Baseline in Total Cholesterol | Baseline, Week 26 |
| Change from Baseline in the EQ-5D-Y-5L | Baseline, Week 26 |
| Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B) | Baseline, Week 26 |
Countries
Argentina, Mexico, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
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