NCT01140893Unknown2 期
Effects of EXEnatide on Glycemic Control and Weight Over 26 Weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients With Type 2 Diabetes : a Phase 2/3 Double Blind randoMized Placebo-controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Change from baseline to 6 months of centrally measured HbA1c
研究概览
简要总结
The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 35 to 70
- •Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :
- •presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random glucose >200 mg/dL) or
- •fasting plasma glucose elevation on more than 1 occasion > 125 mg/dL or
- •patient currently undergoing pharmacological and/or non-pharmacological treatment for diabetes mellitus
- •CSII treatment using a rapid analog for at least 6 month (CSII being initiated in patients with HbA1c > 8 % despite a well-conducted MDI trial using a 2 to 5 daily injection regimen)
- •HbA1c ≥ 7,5% and ≤ 10 %
- •BMI ≥ 25 and ≤ 45
- •Stable body weight (≤10% variation) during the 3 last months
排除标准
- •Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodies
- •Monogenic diabetes (MODY, mitochondrial diabetes...)
- •Current treatment with OHA (OHA ought to be interrupted at least two months prior to inclusion in the study)
- •Current treatment specifically addressed for weight lost (orlistat, sibutramine, rimonabant may be interrupted at least 3 months prior to inclusion in the study)
- •Use of corticosteroid therapy for more than 10 days within the 3-past months, or patient who ought to be treated by corticosteroid during the study period
- •Clinically significant hepatic disease
- •Documented gastroparesis, or current use of drugs that directly affect gastrointestinal motility, or any significant abdominal disease that may increase the risk of adverse gastrointestinal effects induced by exenatide
- •Kidney failure (MDRD less than 50 ml/min)
- •Pregnancy/breastfeeding
- •Any social and/or mental condition rendering the subject unable to understand the scope and possible consequences of the study
- •Concurrent enrolment in another clinical trial
- •Geographically inaccessible for follow-up visits required by protocol
研究组 & 干预措施
exenatide
Experimental
55 subjects
干预措施: Exenatide (Drug)
Placebo
Placebo Comparator
55 subjects
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to 6 months of centrally measured HbA1c
时间窗: baseline to 6 months
次要结局
- Change from baseline in weight, BMI, waist circumference, 6 points glucose profile, insulin doses, % of daily use of insulin as basal rate, % of daily use of insulin as bolus, quality of life questionnaire(baseline to 6 months)
- Change from baseline in mean blood glucose value(baseline to 6 months)
研究者
研究点 (3)
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