Diabetes Mellitus, Type 2
Conditions
Keywords
Pediatric trial, GLP-1 receptor agonist, Oral GLP-1, Small molecule GLP-1, Youth-onset type 2 diabetes, Glycemic control, Continuous glucose monitoring, Non-inferior, Active-controlled
Brief summary
This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them. Participation in the study will last about 61 weeks.
Interventions
DRUGOrforglipron
Administered orally
DRUGDulaglutide
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 * Have HbA1c \> 6.5% to ≤ 11.0% at screening * Have a body weight ≥50 kilograms (kg) (110 pounds) and a body mass index (BMI) of \>85th percentile
Exclusion criteria
* Have type 1 diabetes * After the type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome * Have had at least one episode of severe hypoglycemia and/or at least one episode of hypoglycemic unawareness within the last 6 months before screening * Have a history of pancreatitis or gallbladder disease * Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) * Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or (SGLT2) inhibitors within 90 days prior to screening * Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 90 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 40 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1c | Baseline, Week 52 |
| Percentage of Participants with HbA1c ≤6.5% | Week 40 |
| Percent Change from Baseline in Body Mass Index (BMI) | Baseline, Week 40 |
| Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL | Baseline, during 2 weeks prior to Week 40 |
| Percent Change from Baseline in Body Weight | Baseline, Week 40 |
| Change from Baseline in Blood Pressure | Baseline, Week 40 |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 40 |
| Change from Baseline in Waist Circumference | Baseline, Week 40 |
| Change from Baseline in Tanner Staging | Baseline, Week 52 |
| Change from Baseline in Homeostatic Model Assessment of Beta-cell (HOMA2-B) | Baseline, Week 40 |
| Change from Baseline in the EQ-5D-Y-5L | Baseline, Week 40 |
| Number of Participants by Acceptability Response Category | Baseline, Week 52 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron | Predose through Week 30 |
Countries
Belgium, Brazil, India, Italy, Japan, Mexico, South Korea, Spain, Taiwan, United Kingdom, 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