NCT00729326已完成4 期
Comparison of the Effect of Exenatide vs. Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Change in Time-averaged Glucose During a 24 Hour Period
研究概览
简要总结
This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes
- •Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit
- •Have a fasting glucose concentration <280 mg/dL at Visit 1
- •Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.
- •Are between 18 and 70 years of age, inclusive.
- •Have body mass index ≥25 kg/m2 and ≤45 kg/m
- •Have a history of stable body weight (not varying by >10% for at least 3 months prior to screening).
- •Can swallow oral study drug capsule, without splitting or crushing.
排除标准
- •Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:
- •Are breastfeeding.
- •Test positive for pregnancy at the time of screening.
- •Intend to become pregnant during the study.
- •Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.
- •Treated with any of the following medications:
- •Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening
- •Alpha-glucosidase inhibitor within 2 months of screening.
- •Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
- •Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit
- •Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.
- •Have a history of renal transplantation or are currently receiving renal dialysis.
- •Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.
- •Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.
- •Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- •Have had organ transplantation.
- •Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 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
Sequence A
Experimental
干预措施: exenatide (Drug)
Sequence A
Experimental
干预措施: sitagliptin (Drug)
Sequence A
Experimental
干预措施: placebo (Drug)
Sequence B
Experimental
干预措施: exenatide (Drug)
Sequence B
Experimental
干预措施: sitagliptin (Drug)
Sequence B
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Change in Time-averaged Glucose During a 24 Hour Period
时间窗: baseline and 8 Weeks
Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).
次要结局
- Change in Two-hour Postprandial Glucose After the Morning Meal(baseline and 8 Weeks)
- Change in Fasting Blood Glucose After the Morning Meal(baseline and 8 Weeks)
- Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal(baseline and 8 Weeks)
- Change in Postprandial Glucagon AUC Excursion After the Morning Meal(baseline and 8 Weeks)
- Change in Postprandial Triglyceride AUC After the Morning Meal(baseline and 8 Weeks)
- Change in Postprandial Triglyceride AUC Excursion After the Morning Meal(baseline and 8 Weeks)
- Change in Postprandial C-peptide AUC After the Morning Meal(baseline and 8 Weeks)
- Change in Postprandial C-peptide AUC Excursion After the Morning Meal(baseline and 8 Weeks)
- Change in Postprandial Insulin AUC After the Morning Meal(baseline and 8 Weeks)
- Change in Postprandial Insulin AUC Excursion After the Morning Meal(baseline and 8 Weeks)
- Change in Postprandial Active GLP-1 AUC After the Morning Meal(baseline and 8 Weeks)
- Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal(baseline and 8 Weeks)
- Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)(4 Weeks)
- Episodes of Hypoglycemia (Baseline to Week 4)(4 weeks)
- Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)(8 weeks)
- Episodes of Hypoglycemia (Week 4 to Week 8)(8 weeks)
- Percentage of Patients Experiencing Hypoglycemia (Overall)(4 weeks and 8 weeks)
- Episodes of Hypoglycemia (Overall)(4 weeks and 8 weeks)
研究者
研究点 (1)
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