NCT00603239已完成3 期
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and 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
- 165
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Hemoglobin (HbA1c)
研究概览
简要总结
This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.
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
- •Diagnosed with type 2 diabetes
- •If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
- •The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
- •The metformin dose has been stable for at least 90 days
- •Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
- •Have a body mass index (BMI): 25 kg/m2 < BMI < 45 kg/m2.
排除标准
- •Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs
- •Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
- •Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
- •Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.
- •Are currently treated with any of the following excluded medications:
- •Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
- •Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
- •Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
- •Pramlintide acetate injection within 3 months prior to screening
- •Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
- •Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
研究组 & 干预措施
Exenatide twice daily (BID)
Experimental
干预措施: exenatide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in Glycosylated Hemoglobin (HbA1c)
时间窗: baseline and 26 weeks
Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)
次要结局
- Percentage of Patients Achieving HbA1c <= 7%(26 weeks)
- Percentage of Patients Achieving HbA1c <= 6.5%(26 weeks)
- Change in Fasting Serum Glucose (FSG)(baseline and 26 weeks)
- Change in Body Weight(baseline and 26 weeks)
- Change in Beta-cell Function(baseline and 26 weeks)
- Change in Waist Circumference(baseline and 26 weeks)
- Change in Insulin Sensitivity.(baseline and 26 weeks)
- Number of Subjects Who Experienced an Episode of Minor Hypoglycemia(26 weeks)
- Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score(baseline and 26 weeks)
- Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score(baseline and 26 weeks)
研究者
研究点 (1)
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