A Single-center,Proof of Concept,Randomized,Controlled Parallel Group Clinical Trial of the Effects of Exenatide vs. a Long Acting Insulin Analog to Evaluate the Efficacy of Exenatide in Patients With Diabetic Neuropathy and Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Confirmed Clinical Neuropathy (CCN)
研究概览
简要总结
This study will look at whether or not the medication exenatide improves signs and symptoms of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate diabetic peripheral neuropathy.
详细描述
This study will look at the effects of the medication exenatide on peripheral neuropathy in people with type 2 diabetes. Exenatide (trade name, BYETTA®) is an injectable medication used by people with type 2 diabetes to control blood sugar. Peripheral neuropathy is a complication of diabetes that can cause symptoms such as numbness, tingling or burning sensations in the feet and hands. Controlling blood sugars levels in type 2 diabetes is thought to prevent, delay or improve the damage to the nerve fibers that causes peripheral neuropathy. There is also some evidence that exenatide may have additional beneficial effects on the peripheral nerves, beyond the benefits of blood sugar control alone. In this study, about half of the participants will take exenatide by injection twice daily and the other half will take insulin glargine (Lantus®) by injection once daily. Both groups are expected to have similar improvement in blood sugar control. This study will show whether exenatide has beneficial effects on neuropathy beyond the benefits of better blood sugar control alone.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes treated with one or more oral agents
- •Persistent fasting glucose > 140 mg/dl or HbA1c > 7%
- •Stable and maximally effective doses of one or more oral agents for 3 months
- •Presence of diabetic peripheral neuropathy
- •Age between 18 and 70 years
- •No risk factors or other causes of neuropathy
- •Willingness and capacity to sign the Institutional Review Board approved consent form and cooperate with the medical procedures for study duration
排除标准
- •Nursing mothers or pregnant women
- •A history of previous kidney, pancreas or cardiac transplantation
- •A past history of neuropathy (independent of diabetes) or with a disease known to be associated with neuropathy (e.g., hepatitis C, end stage renal disease, lupus)
- •Amputation of any part of either lower extremity for any reason or traumatic loss of any part of either lower extremity or congenital absence or severe deformity of lower extremity
- •HbA1c > 10%
- •Participation in an experimental medication trial within 3 months of starting the study.
- •Undergoing therapy for malignant disease other than basal- or squamous cell carcinoma
- •Requiring long-term glucocorticoid therapy
- •Inability or unwillingness to comply with the protocol
研究组 & 干预措施
Exenatide
Subjects will take exenatide by subcutaneous injection twice daily for 18 months
干预措施: Exenatide (Drug)
glargine
Subjects will take 1 daily injection of insulin glargine for 18 months.
干预措施: Glargine (Drug)
结局指标
主要结局
Confirmed Clinical Neuropathy (CCN)
时间窗: 18 Months
CCN was defined by a composite score comprised of at least two positive responses among symptoms, sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy (16), and at least one abnormal nerve conduction study result in two anatomically distinct nerves, e.g. the sural sensory and peroneal motor nerves (defined as a amplitude \< 5 μV and a conduction velocity \< 40 m/sec for the sural nerve and an amplitude \< 2.5 μV and a conduction velocity \< 40 m/sec for the peroneal nerve).
次要结局
- Cardiac Autonomic Neuropathy (CAN)(18 months)
- Cardiac Autonomic Neuropathy(18 month)
研究者
Rodica Pop-Busui
Assistant Professor of Internal Medicine
University of Michigan