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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 61
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes, 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.
- •Have HbA1c >6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between >6.5 % to ≤9%.
- •Have a BMI (body mass index) >85 percentile for age, gender and body weight ≥50 kilograms (110 pounds).
排除标准
- •Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.
- •A history of, or at risk for pancreatitis.
- •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 milliliter (pg/ml) at screening.
- •A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg.
- •Active or treated cancer.
- •A blood disorder where an accurate HbA1c may not be obtainable.
- •A female of childbearing age, sexually active and not on birth control.
- •Pregnant or plan to be pregnant during the study, or breastfeeding.
- •Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin).
- •Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day.
- •Using prescription weight loss medications in the last 30 days, or plan to use.
- •Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.
研究组 & 干预措施
Placebo/0.75 milligram (mg) Dulaglutide
Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE).
干预措施: Dulaglutide (Drug)
Placebo/0.75 milligram (mg) Dulaglutide
Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE).
干预措施: Placebo (Drug)
0.75 mg Dulaglutide
Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.
干预措施: Dulaglutide (Drug)
1.5 mg Dulaglutide
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26
时间窗: Baseline, Week 26
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).
次要结局
- Percentage of Participants With Self-Reported Events of Hypoglycemia(Week 26)
- Change From Baseline in Pancreatic Enzymes at Week 26(Baseline, Week 26)
- Number of Participants With Thyroid Treatment-Emergent Adverse Events(Week 26)
- Percentage of Participants With Injection Site Reactions(Week 26)
- Number of Participants With Adjudicated Pancreatitis(Week 26)
- Change From Baseline in HbA1c (Individual Doses) at Week 26(Baseline, Week 26)
- Change From Baseline in Fasting Blood Glucose (FBG) at Week 26(Baseline, Week 26)
- Change From Baseline in Body Mass Index (BMI) at Week 26(Baseline, Week 26)
- Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia(Week 26)
- Percentage of Participants With HbA1c ≤7.0%(Week 26)
- Change From Baseline in Serum Calcitonin at Week 26(Baseline, Week 26)
- Percentage of Participants With Allergic, Hypersensitivity Reactions(Week 26)
- PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss](Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit)
- Number of Participants With Anti-Dulaglutide Antibodies(Baseline through Week 56)
- Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)(Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit)