NCT01003184已完成3 期
Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulphonylurea
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
- 222
- 试验地点
- 1
- 主要终点
- Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)
研究概览
简要总结
The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive
- •Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive
- •Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start
排除标准
- •Have any contraindication for the OAD that they have been using
- •Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
- •Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease)
- •Have been treated with drugs that promote weight loss, within 3 months of screening
- •Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors
- •Have previously completed or withdrawn from this study or any other study investigating exenatide QW
- •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
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
研究组 & 干预措施
2
Active Comparator
干预措施: insulin detemir (Drug)
1
Experimental
干预措施: exenatide once weekly (Drug)
结局指标
主要结局
Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)
时间窗: Baseline, Week 26
The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c \<=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.
次要结局
- Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)(Baseline, Week 26)
- Change in Body Weight From Baseline to Week 26(Baseline, Week 26)
- Percentage of Patients Achieving ≤6.5% at Endpoint(Week 26)
- Change in HbA1c From Baseline to Week 26(Baseline, Week 26)
- Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint(Week 26)
- Percentage of Patients Achieving ≤7.0% at Endpoint(Week 26)
- Changes in Systolic Blood Pressure From Baseline to Week 26(Baseline, Week 26)
- Change in Triglycerides From Baseline to Endpoint (Week 26).(Baseline, Week 26)
- Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).(Baseline, Week 26)
- Change in Diastolic Blood Pressure From Baseline to Week 26.(Baseline, Week 26)
- Change in Total Cholesterol From Baseline to Endpoint (Week 26).(Baseline, Week 26)
- Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).(Baseline, Week 26)
- Hypoglycemia Rate Per Year(Baseline, Week 26)
研究者
研究点 (1)
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