NCT00935532已完成3 期
Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)
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
- 427
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline to Endpoint (Week 26)
研究概览
简要总结
The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.
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
- •present with type 2 diabetes mellitus
- •HbA1c between 7.1% and 11.0% inclusive
- •body mass index (BMI) of >18kg/m2 and <35kg/m2, inclusive
- •treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start
排除标准
- •Have received chronic (>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.
- •Have been treated with drugs that promote weight loss within 90 days prior to study start.
- •Have been treated with drugs that directly affect gastrointestinal motility for > 21 consecutive days within 90 days prior to study start.
- •Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).
- •Have been treated for >2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs
- •Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.
- •Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.
- •Have donated blood within 30 days prior to study start.
研究组 & 干预措施
exenatide once weekly
Experimental
干预措施: exenatide once weekly (Drug)
insulin glargine
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Endpoint (Week 26)
时间窗: Baseline, Week 26
Change in HbA1c from baseline to endpoint (Week 26).
次要结局
- Percentage of Subjects Achieving HbA1c<=6.5%(Baseline, Week 26)
- Change in Total Cholesterol From Baseline to Endpoint (Week 26)(Baseline, Week 26)
- Change in Blood Pressure From Baseline to Endpoint (Week 26)(Baseline, Week 26)
- Change in Body Weight From Baseline to Endpoint (Week 26)(Baseline, Week 26)
- Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)(Baseline, Week 26)
- Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline(Baseline, Week 26)
- Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events(Baseline to Week 26)
- Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events(Baseline to Week 26)
- Percentage of Subjects Achieving HbA1c<=7%(Baseline, Week 26)
- Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)(Baseline, Week 26)
研究者
研究点 (1)
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