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A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
55 patients around the world
Available in Argentina, United States, Mexico
Eli Lilly and Company
7Research sites
55Patients around the world
This study is for people with
Diabetes
Diabetes mellitus type 2
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.
- Have Type 1 diabetes.Have received treatment with any glucose-lowering agent(s) other than metformin or basal insulin 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.
Sites
Clínica Mayo de UMCB SRL - Tucumán
Centro Médico Maffei - CABA, Buenos Aires
INECO Neurociencias Oroño - Rosario
Go Centro Médico San Nicolás
Centro de Investigaciones Médicas Mar del Plata SRL
Arke Estudios Clínicos S.A. de C.V. - Veracruz
Hospital Ángeles Puebla
StudyAWARD-PEDS PLUS
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Diabetes mellitus type 2
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06739122
