NCT00870194已完成4 期
A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Percent)
研究概览
简要总结
The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present with type 2 diabetes
- •Patients have been treated with a stable dose of the following for at least 3 months prior to screening:
- •100 mg/day sitagliptin and
- •≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).
- •Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.
- •Have a body mass index (BMI) ≥20 kg/m2 and <45 kg/m2
排除标准
- •Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Have previously completed or withdrawn from this study or any other study investigating exenatide.
- •Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.
- •Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.
- •Are currently treated with any of the following excluded medications:
- •Thiazolidinediones (TZD) within 3 months of screening.
- •Sulfonylurea (SU) within 3 months of screening.
- •Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening.
- •Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.
- •Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.
- •Exogenous insulin within the 3 months prior to screening.
- •Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.
- •Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.
- •Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.
研究组 & 干预措施
1
Experimental
干预措施: exenatide and sitagliptin (Drug)
2
Placebo Comparator
干预措施: exenatide and placebo (Drug)
结局指标
主要结局
Change in HbA1c (Percent)
时间窗: Baseline to 20 Weeks
Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values \[X% - Y%\]
次要结局
- Change in Body Weight (kg)(Baseline to 20 Weeks)
- Percentage of Patients Achieving HbA1c <=7.0%(Baseline to 20 Weeks)
- Percentage of Patients Achieving HbA1c <7.0%(Baseline to 20 Weeks)
- Percentage of Patients Achieving HbA1c <=6.5%(Baseline to 20 Weeks)
- Change in FSG (mmol/L)(Baseline to 20 Weeks)
- Change in Waist Circumference (cm)(Baseline to 20 Weeks)
- Waist-to-Hip Ratio(Baseline to 20 Weeks)
- SMBG (mmol/L)(Baseline to 20 Weeks)
- Change in Triglycerides (mmol/L)(Baseline to 20 Weeks)
- Change in HDL (mmol/L)(Baseline to 20 Weeks)
- Change in LDL (mmol/L)(Baseline to 20 Weeks)
- Change in Total Cholesterol (mmol/L)(Baseline to 20 Weeks)
- Incidence of Hypoglycemia (Overall)(Baseline to 20 Weeks)
- Incidence of Severe Hypoglycemia(Overall)(Baseline to 20 Weeks)
- Incidence of Nocturnal Hypoglycemia (Overall)(Baseline to 20 Weeks)
- Incidence of Confirmed Hypoglycemia(Overall)(Baseline to 20 Weeks)
研究者
研究点 (1)
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