Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28
研究概览
简要总结
The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetes agents, or patients who are being treated with metformin, an SU, or a combination of metformin and an SU
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Subcutaneous injection, twice a day
干预措施: Placebo (Drug)
Exenatide 5 µg
Subcutaneous injection, twice a day
干预措施: Exenatide (Drug)
Exenatide 10 µg
Subcutaneous injection, twice a day
干预措施: Exenatide (Drug)
结局指标
主要结局
Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28
时间窗: Baseline (Day 1) and Week 28
Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period
时间窗: From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.
Post-treatment adverse events (AEs) were defined as AEs that started or worsened during the off-treatment period (Safety Follow-up Period), which was defined as the day after the Week 28/early discontinuation (ED) visit to the date of completion of the Safety Follow-up Period. The AESIs recorded were as follows: hematological malignancies, thyroid neoplasms, pancreas neoplasms, aplastic anemia, pancreatitis, pregnancy and pregnancy outcomes (including congenital anomalies).
次要结局
- Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28(Weeks 0, 4, 12, 20 and 28)
- Adjusted Change From Baseline in Body Weight Through Week 28(Baseline (Day 1) up to Week 28)
- Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28(Baseline (Day 1) and Week 28)
- Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28(Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28)
- Adjusted Change From Baseline in Fasting Serum Insulin at Week 28(Baseline (Day 1) and Week 28)
- Adjusted Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28(Baseline (Day 1) and Week 28)
- Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28(Weeks 2, 4, 8, 12, 16, 20, 24 and 28)