NCT00917267已完成3 期
A Comparator-Controlled Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control (HbA1c) and Safety in Asian Subjects With Type 2 Diabetes Mellitus Managed With Oral Antidiabetic Medications
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 691
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline to Week 26.
研究概览
简要总结
Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with type 2 diabetes.
- •Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.
- •Have a body mass index (BMI) of >21 kg/m2 and <35 kg/m2, inclusive.
- •Have a history of stable body weight (not varying by >5% for at least 90 days prior to study start).
- •Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.
排除标准
- •Have any contraindication for the OAD(s) that they use.
- •Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.
- •Have received chronic >14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.
- •Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.
- •Have been treated for >2 weeks with any of the following excluded medications within 90 days prior to study start:
- •Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)
- •Pramlintide acetate
- •Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
- •Have had prior exposure to exenatide
- •Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Are currently enrolled in any other clinical study.
研究组 & 干预措施
1
Experimental
干预措施: exenatide once weekly (Drug)
2
Active Comparator
干预措施: exenatide twice daily (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 26.
时间窗: Baseline, Week 26
Change in HbA1c from baseline to Week 26.
次要结局
- Change in Body Weight (BW) From Baseline to Week 26(Baseline, Week 26)
- Change in Total Cholesterol (TC) From Baseline to Week 26(Baseline, Week 26)
- Change in High-Density Lipoprotein (HDL) From Baseline to Week 26(Baseline, Week 26)
- Ratio of Triglycerides (TG) at Week 26 to Baseline(Baseline, Week 26)
- Percentage of Patients Achieving HbA1c Targets <=7% at Week 26(Baseline, Week 26)
- Change in Blood Pressure From Baseline to Week 26(Baseline, Week 26)
- Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26(Baseline, Week 26)
- Change in Fasting Serum Glucose (FSG) From Baseline to Week 26(Baseline, Week 26)
- Assessment of Event Rate of Treatment-emergent Hypoglycemic Events(Baseline to Week 26)
研究者
研究点 (1)
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