NCT00360334已完成3 期
An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone
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
- 235
- 试验地点
- 1
- 主要终点
- Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
研究概览
简要总结
This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.
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
- 30 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
- •Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
- •HbA1c between 7.5% and 10.0%.
- •BMI >27.
排除标准
- •Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.
- •Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
- •Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months.
- •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.
研究组 & 干预措施
1
Experimental
干预措施: exenatide (Drug)
2
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
时间窗: 26 weeks
Composite endpoint evaluating effect of treatment on glycemic control and weight
次要结局
- Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg(26 weeks)
- Change in Fasting Serum Glucose(26 weeks)
- Percent of Patients Achieving HbA1c ≤ 7.4%(26 weeks)
- Percent of Patients Achieving HbA1c < 7%(26 weeks)
- Percent of Patients Achieving HbA1c < 6.5%(26 weeks)
- Change in 7 Point Self Monitored Blood Glucose Profile(26 weeks)
- Change in Body Mass Index (BMI)(26 weeks)
- Change in Waist Circumference(26 Weeks)
- Change in Waist-to-hip Ratio(26 weeks)
- Change in Body Weight(26 weeks)
- Percent Change in Body Weight(26 Weeks)
- Percent of Patients Achieving 5% Weight Loss(26 weeks)
- Percent of Patients Achieving 10% Weight Loss(26 weeks)
- Change in Systolic Blood Pressure(26 weeks)
- Change in Diastolic Blood Pressure(26 weeks)
- Change in Fasting Serum Total Cholesterol (TC)(26 weeks)
- Change in High Density Lipoprotein (HDL) Cholesterol(26 weeks)
- Change in TC to HDL Cholesterol Ratio(26 weeks)
- Change in Fasting Serum Triglycerides(26 weeks)
- Change in Low Density Lipoprotein (LDL) Cholesterol(26 weeks)
- Change in Apolipoprotein-B(26 weeks)
- Incidence of Hypoglycemic Episodes(26 weeks)
- Incidence of Nocturnal Hypoglycemic Episodes(26 weeks)
- Incidence of Severe Hypoglycemic Episodes(26 weeks)
- Hypoglycemic Rate Per 30 Days(26 weeks)
- Nocturnal Hypoglycemic Rate Per 30 Days(26 weeks)
- Severe Hypoglycemic Rate Per 30 Days(26 weeks)
研究者
研究点 (1)
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