EUCTR2016-000361-22-GB进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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. Except for bolus insulin, all other diabetic medications must have been stopped at least 3 months before the screening visit. Patients should not have received bolus insulin within 6 weeks of the screening visit, except as rescue treatment for management of acute medical conditions for a maximum of 14 days.
- •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.
研究者
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