A Randomized, Double-Blind Study with an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide with Placebo in Pediatric Patients with Type 2 Diabetes Mellitus - AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study

Eli Lilly and Company0 个研究点目标入组 150 人开始时间: 2017年2月27日最近更新: 2018年1月8日

研究概览

暂无简介。

•1. Age 10 to less than 18 years old
•2. Have type 2 diabetes mellitus, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening
•7. Have a HbA1c of > 6.5 or = 11. If you are newly diagnosed, have a HbA1c in the range of > 6.5 or = 9.
•8. Weight is at least 110 pounds or 50 kg
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 150
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Known type 1 diabetes, or positive GAD 6 or IA2 antibodies, or history of diabetic ketoacidosis after taking diabetes medication.
•2. A history or, or at risk for pancreatitis
•3. Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid c-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result => 20 picograms per millilter (pg/ml) at screening.
•4. A systolic blood pressure rate of => 160 millimeters of mercury (mmHg) or diastolic => 100 mmHg.
•5. Active or treated cancer
•6. A blood disorder where an accurate HbA1c may not be obtained.
•7. A female of childbearing age, sexually active and not on birth control.
•8. Pregnant or plan to be pregnant during the study, or breastfeeding.
•9.Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit.
•10. Have taken oral steroids within the last 60 days or more than 20 days use withing the past year or 1000 mcg of fluticasone propionate per day.
•11. Using prescription weight loss medications in the last 30 days or plan to use them.
•12. Taking psychiatric medications for depression or illness or attention deficit hyperactivity disroder (ADHD) if, the doses have changed within the last 3 months.

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