A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
About this study
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.
- Condition
- Type 2 Diabetes
- Tested
- Dulaglutide
- Sponsor
- Eli Lilly and Company
Who can join
- Age
- 10 to 17 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 5
- Minimum age: 10 years
- Maximum age: 17 years
- Study condition: Type 2 Diabetes
- 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 7
- 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
51 sites, 51 recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina
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
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
and 45 more sites on ClinicalTrials.gov
Contact
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559 LillyTrials@Lilly.com
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Physicians interested in becoming principal investigators please contact
Potential match only. Final eligibility is determined by the study team.