Recruiting NCT06739122
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dulaglutide.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 10 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug Dulaglutide
Administered SC
Primary outcome measures
- 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]
Secondary outcome measures (7)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide [Time frame: Predose through Week 30]
- PK: Maximum Observed Concentration (Cmax) of Dulaglutide [Time frame: Predose through Week 30]
- Change from Baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline, Week 26]
- Percent Change from Baseline in Body Weight [Time frame: Baseline, Week 26]
- Change from Baseline in Total Cholesterol [Time frame: Baseline, Week 26]
- Change from Baseline in the EQ-5D-Y-5L [Time frame: Baseline, Week 26]
- Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B) [Time frame: Baseline, Week 26]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 41 centers
- University of Arizona — Tucson
- Arkansas Childrens Hospital — Little Rock
- Division of Endocrinology, Diabetes, and Metabolism — Los Angeles
- UCLA Mattel Children's Hospital — Los Angeles
- University of California, San Francisco — San Francisco
- Children's Hospital of Colorado — Denver
- Yale Diabetes Research — New Haven
- Emerson Clinical Research Institute — Washington D.C.
- … and 33 more centers
Argentina · 5 centers
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Buenos Aires
- Centro de Investigaciones Médicas Mar del Plata — Mar del Plata
- INECO Neurociencias Oroño — Rosario
- Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L — San Miguel de Tucumán
- Go Centro Medico San Nicolás — San Nicolás
Mexico · 5 centers
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares — Ciudad Madero
- Hospital Angeles (HA) - Puebla — Puebla City
- Clínica Cemain — Tampico
- Innovacion y Desarrollo de Estrategias en Salud SA de CV — Tlalpan
- Arké SMO S.A de C.V — Veracruz
Identifiers
NCT: NCT06739122 · 27198 · H9X-MC-GBGS