A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
Recruiting · NCT06739122 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Dulaglutide
What this trial is about
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.
Who can take part
Age range
10 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
51 locations listed across 26 US states.
- University of Arizona - Tucson, Arizona, United States
- Arkansas Childrens Hospital - Little Rock, Arkansas, United States
- Division of Endocrinology, Diabetes, and Metabolism - Los Angeles, California, United States
- UCLA Mattel Children's Hospital - Los Angeles, California, United States
- University of California, San Francisco - San Francisco, California, United States
- Children's Hospital of Colorado - Denver, Colorado, United States
- Yale Diabetes Research - New Haven, Connecticut, United States
- Emerson Clinical Research Institute - Washington D.C., District of Columbia, United States
- Children's National Medical Center - Washington D.C., District of Columbia, United States
- Nemours Children's Health - Jacksonville, Florida, United States
- D&H National Research Centers, Inc - Miami, Florida, United States
- AdventHealth Orlando - Orlando, Florida, United States
- D&H Tamarac Research Center, LLC - Tamarac, Florida, United States
- University of South Florida - Tampa, Florida, United States
- Children's Healthcare of Atlanta - Center for Advanced Pediatrics - Atlanta, Georgia, United States
- Centricity Research Columbus Endocrinology - Columbus, Georgia, United States
- St. Luke's Children's Endocrinology and Diabetes - Boise, Idaho, United States
- University of Illinois at Chicago - Chicago, Illinois, United States
- Center for Diabetes and Metabolic Diseases Indiana University - Indianapolis, Indiana, United States
- University of Iowa Stead Family Children's Hospitals - Iowa City, Iowa, United States
- Norton Children's Endocrinology - Louisville, Kentucky, United States
- Johns Hopkins University School of Medicine - Baltimore, Maryland, United States
- University of Mississippi Medical Center - Jackson, Mississippi, United States
- University of New Mexico Hospital - Albuquerque, New Mexico, United States
- WBMD Pediatrics - Buffalo, New York, United States
- Cohen Children's Medical Center Division of Pediatric Endocrinology - Hyde Park, New York, United States
- SUNY Upstate Medical University - Syracuse, New York, United States
- UNC Children's Hospital - Chapel Hill, North Carolina, United States
- Childrens Hospital Medical Center - Cincinnati, Ohio, United States
- Cleveland Clinic Childrens Outpatient Center - Cleveland, Ohio, United States
- University of Oklahoma Health Sciences Center - Oklahoma City, Oklahoma, United States
- Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States
- St Christophers Hospital For Children - Philadelphia, Pennsylvania, United States
- Prisma Health Pediatric Endocrinology - Columbia, South Carolina, United States
- Prisma Health Midlands - Greenville, South Carolina, United States
- Research Institute of Dallas - Dallas, Texas, United States
- Texas Childrens Hospital - Houston, Texas, United States
- UT Health Houston - Houston, Texas, United States
- University of Utah - Salt Lake City, Utah, United States
- Seattle Children's Hospital - Seattle, Washington, United States
- Children's Wisconsin - Milwaukee Campus - Milwaukee, Wisconsin, United States
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada - Buenos Aires, Argentina
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares - Ciudad Madero, Mexico
- Centro de Investigaciones Médicas Mar del Plata - Mar del Plata, Argentina
- Hospital Angeles (HA) - Puebla - Puebla City, Mexico
- INECO Neurociencias Oroño - Rosario, Argentina
- Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L - San Miguel de Tucumán, Argentina
- Go Centro Medico San Nicolás - San Nicolás, Argentina
- Clínica Cemain - Tampico, Mexico
- Innovacion y Desarrollo de Estrategias en Salud SA de CV - Tlalpan, Mexico
- Arké SMO S.A de C.V - Veracruz, Mexico