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A Study of Dulaglutide (LY2189265) [amount hidden] in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
Plain-language guide to NCT06739122: phase 3 interventional trial of Dulaglutide, 55 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06739122
- Phase
- phase 3
- Status
- recruiting participants
- Start
- 2025-01-10
- Completion (planned or actual)
- 2027-12
- Participants
- 55 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Dulaglutide.
Participation in this study will last about 8 months.
It had 1 arm (groups): Dulaglutide (experimental).
Participants will receive dulaglutide subcutaneously (SC).
The registry classes the interventions as drug.
Who Took Part
The registry lists 55 planned participants were the target.
It was open to people of any sex aged from 10 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile.
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: 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.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Dulaglutide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2025-01-10 with completion listed for 2027-12.
It ran at 51 sites in United States (41), Argentina (5) and Mexico (5).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Week 26).
It also tracked 7 secondary outcomes, for example PK: Maximum Observed Concentration (Cmax) of Dulaglutide, Change from Baseline in Hemoglobin A1c (HbA1c), Percent Change from Baseline in Body Weight, Change from Baseline in Total Cholesterol, Change from Baseline in the EQ-5D-Y-5L and Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B).
What This Means in Plain Language
Put simply, this is a phase 3 trial of Dulaglutide in 55 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Dulaglutide compound page, all human trials.
Our Notes on the Compound
Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.