NCT01474018已完成4 期
QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in A1c
研究概览
简要总结
QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2 diabetes will result in improved glycemic control, reduced exogenous insulin requirement, increased lean fat mass and improved pancreatic beta-cell function.
详细描述
To assess improvement in glycemic control, reliance on exogenous insulin, improvements in lean body mass composition, and improvements in pancreatic beta-cell function.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients, age 30 to 65 years of age,
- •Clinical diagnosis of type 2 diabetes at least 6 months prior to enrollment,
- •Stable on current treatment consisting of either human or recombinant multi-dose insulin therapy (MDI) with metformin,
- •HbA1c of 7.5-12%, inclusive,
- •Demonstrated willingness to check and record blood glucose readings at seven time points as instructed in the study protocol.
- •Medically controlled hypertension, at least on one anti-hypertensive
- •Medically controlled hyperlipidemia, on or off cholesterol-lowering therapy
排除标准
- •Pregnancy or Lactating,
- •Type 1 Diabetes,
- •Concomitant use of forbidden medications: prescription sympathomimetics (within seven days of screening), ergot alkaloid derivatives, and anti-migraine medications,
- •Patients with history of drug or alcohol abuse within 3 years of enrollment,
- •Patients at risk for hypotension, including those who have:
- •Recent blood donation within 30 days of enrollment,
- •A history of syncopal migraines, or
- •Significant gastroparesis or orthostatic hypotension which could signify advanced autonomic neuropathy.
- •Uncontrolled mental illness especially with history of psychosis,
- •Any severe, uncontrolled or terminal medical condition which the investigator feels would interfere with the patient's ability to participate and comply with the study protocol,
- •Serum creatinine >1.4mg/dL in females or >1.5mg/dL in males that would preclude the patient from taking metformin,
- •LFTs elevated >3x upper limit of normal,
- •Patients working rotating, varying or night shifts, or
- •Patient with circumstances or abnormalities (e.g. blindness or history of non-compliance) that would interfere with the interpretation of safety or efficacy data or completion of the study.
研究组 & 干预措施
QR-Bromocriptine +metformin+insulin
Experimental
study drug add-on the usual therapy
干预措施: QR-bromocriptine (Drug)
结局指标
主要结局
Change in A1c
时间窗: Baseline - 24 weeks
Change from baseline HbA1c between subjects receiving QR-Bromocriptine + metformin + insulin compared to those subjects receiving metformin + insulin
次要结局
- Total Daily Insulin Dose(Baseline - 24 weeks)
研究者
研究点 (2)
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