Tests higher dulaglutide doses in children with type 2 diabetes
Tests two dulaglutide doses in children aged 10 to 17 with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
Key facts
- Where
- Buenos Aires, Mar del Plata, Rosario, San Miguel de Tucumán, and San Nicolás, ArgentinaSee the 5 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Source: NCT06739122, who can take part
Where in Argentina
- Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaBuenos Aires, ArgentinaTaking people
- Centro de Investigaciones Medicas Mar Del PlataMar del Plata, ArgentinaNot yet recruiting
- INECO Neurociencias OroñoRosario, ArgentinaTaking people
- Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.LSan Miguel de Tucumán, ArgentinaTaking people
- Go Centro Medico San NicolásSan Nicolás, ArgentinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06739122
- Record updated
- 7 August 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 mg and 4.5 mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus
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.
Inclusion: 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: 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; Have Type 1 diabetes; After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome; Have family or personal 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 dulaglutide within 8 weeks prior to screening; Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.