NCT00577824已完成3 期
Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled
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
- 181
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24
研究概览
简要总结
This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes.
- •Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.
- •Have HbA1c 7.0% to 10% at study start.
- •Have a body weight >=50 kg.
排除标准
- •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.
- •Have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (GLP-1) analogs within the last 90 days.
- •Have been treated with any exogenous insulin within 90 days before study start.
- •Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.
- •The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.
研究组 & 干预措施
1
Experimental
干预措施: exenatide (Drug)
2
Experimental
干预措施: exenatide (Drug)
3
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24
时间窗: baseline, 24 weeks
Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
次要结局
- Change in Body Weight(baseline, week 24)
- Change in High Density Lipoprotein Cholesterol (HDL-C)(baseline, week 24)
- Percentage of Patients Achieving HbA1c < 7.0%(24 weeks)
- Percentage of Patients Achieving HbA1c < 6.5%(24 weeks)
- Change in Fasting Blood Glucose(baseline, week 24)
- 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24(baseline, week 24)
- Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)(baseline, week 24)
- Change in C-peptide(baseline, week 24)
- Change in Low Density Lipoprotein Cholesterol (LDL-C)(baseline, week 24)
- Change in Waist-to-hip Ratio(baseline, week 24)
- Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)(baseline, week 24)
- Change in Total Cholesterol(baseline, week 24)
- Change in Triglycerides(baseline, week 24)
- Change in Serum Insulin(baseline, week 24)
- Change in Waist Size(baseline, week 24)
- Change in 1,5-anhydroglucitol(baseline, week 24)
研究者
研究点 (1)
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