A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Type 2 Diabetes
Спонсор: Eli Lilly and Company
Налично на:
БГ
Обобщение
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.
Кой може да участва
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
Интервенции
Dulaglutide
DRUG
Места на провеждане
51
Argentina (5)
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
БГ
EN