NCT00637273已完成3 期
A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
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
- 514
- 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
This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has been diagnosed with type 2 diabetes mellitus
- •Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
- •Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
- •Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
- •Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
- •Hormone replacement therapy (female subjects)
- •Oral contraceptives (female subjects)
- •Antihypertensive agents
- •Lipid-lowering agents
- •Thyroid replacement therapy
- •Antidepressant agents
- •Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents
排除标准
- •Has been previously exposed to exenatide once weekly
- •Has donated blood within 60 days of study start or is planning to donate blood during the study
- •Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
- •Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
- •Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
- •Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
- •Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
- •Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
- •Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
- •Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use
研究组 & 干预措施
2
Active Comparator
干预措施: placebo once weekly (Drug)
1
Experimental
干预措施: exenatide once weekly (Drug)
1
Experimental
干预措施: placebo tablet (Drug)
2
Active Comparator
干预措施: sitagliptin (Drug)
3
Active Comparator
干预措施: pioglitazone (Drug)
3
Active Comparator
干预措施: placebo once weekly (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 26
时间窗: Day 1, Week 26
Absolute change in HbA1c from baseline (Day 1) to Week 26 \[Week 26 - Baseline\].
次要结局
- Percentage of Subjects Achieving HbA1c Target of <7% at Week 26(Week 26)
- Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26(Week 26)
- Change in Body Weight From Baseline to Week 26(Day 1, Week 26)
- Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26(Day 1, Week 26)
- Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26(Week 26)
- Change in Fasting Plasma Glucose From Baseline to Week 26(Day 1, Week 26)
- Change in Systolic Blood Pressure From Baseline to Week 26(Day 1, Week 26)
- Change in Diastolic Blood Pressure From Baseline to Week 26(Day 1, Week 26)
- Change in Fasting Total Cholesterol From Baseline to Week 26(Day 1, Week 26)
- Assessment on Event Rate of Treatment-emergent Hypoglycemic Events(Day 1 to Week 26)
- Ratio of Fasting Triglycerides at Week 26 to Baseline(Day 1, Week 26)
研究者
研究点 (1)
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