A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 8
- 主要终点
- Change From Baseline in HbA1c Levels
研究概览
简要总结
The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D)
详细描述
This is a multi-site randomized placebo controlled trial of Bydureon in patients with type I diabetes (T1D) of at least 2 years duration who may or may not still have detectable levels of C-peptide during a mixed meal tolerance test (MMTT). Bydureon is a recently approved long acting form of Exenatide. Because of the lack of safety data for Bydureon in children, we propose to conduct the trial in adults (>18 yrs.).
Both the subject and the study personnel will be blinded to treatment assignment. The randomization will be done, 1;1, by the coordinating site (at Yale). As a secondary analysis, we propose to determine whether the presence of residual insulin production modifies the drug effect. To do this, we plan to stratify patients for randomization on the basis of detectable C-peptide levels. We will therefore wait for the results of the C-peptide levels from the enrollment MMTT prior to randomization. The study investigators will not be told in which stratum the patient is being randomized and will be blinded to the C-peptide results of the MMTT until the conclusion of the study.
Note: The primary and study completion dates were changed 4/2016 to reflect an extension of the recruitment and accrual periods.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Inability or unwillingness to give informed consent
- •Current or prior use of immunomodulators or systemic steroids in the last 6 months that could potentially affect diabetes or immunologic status.
- •Known hypersensitivity to Exenatide, Liraglutide or any product component.
- •Participation in an investigational treatment trial within the last 6 weeks before enrollment.
- •1 or more episodes of hypoglycemia (loss of consciousness or requiring the help of others) within the last 6 months.
- •Another condition that would, in the view of the investigator, affect the safety of using Bydureon. This might include, among others a history of MEN 2, a history of medullary carcinoma of the thyroid or pancreatitis.
- •Known severe renal impairment, end-stage renal disease or renal transplantation.
- •Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma.
- •Uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment.
- •Clinically active serious infection.
- •Positive pregnancy test in menstruating women or lactating females.
- •Concurrent use of Pramlinitide, other Incretin medications, or other anti-diabetes medications other than insulin.
研究组 & 干预措施
Placebo
2 mg, 1 per week via subcutaneous placebo self injection
干预措施: Placebo (Drug)
Exenatide (Bydureon)
2 mg, of drug administration 1 per week via subcutaneous self injection
干预措施: Exenatide (Bydureon®) (Drug)
结局指标
主要结局
Change From Baseline in HbA1c Levels
时间窗: 6 months
次要结局
- Change From Baseline in HbA1c Levels(12 months)
- Major Hypoglycemic Event Rate On Drug(Up to 6 months)
- Major Hypoglycemic Event Rate Off Drug(Up to 12 months)