A Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of Pramlintide Acetate When Administered by Subcutaneous Infusion in a Basal-Bolus Manner as an Adjunct to Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Fasting and postprandial pramlintide pharmacokinetics
研究概览
简要总结
This research project will investigate the effects of pramlintide (Symlin) given by continuous subcutaneous (under the skin) infusion throughout the day and night, along with meal doses similar to those injected during conventional pramlintide (Symlin) treatment, delivered using a second insulin pump, in subjects with inadequately controlled type I diabetes mellitus who are already using insulin pump therapy. Study participants will wear two pumps for a four month period, taking insulin in their usual manner and pramlintide (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three occasions during the study to assess blood glucose responses to continuous pramlintide (Symlin) treatment.
详细描述
DESCRIPTION OF STUDY:
To participate in the study, you must have Type I diabetes mellitus and be taking insulin using an insulin pump, and have a hemoglobin A1c level between 7.0% and 10.0%. You will not be permitted to participate in the study if you have taken pramlintide (Symlin) during the previous three months. The study will consist of seven visits to the Study Center over a four-month period. Subjects will undergo meal tolerance testing at beginning and end of study period. Continuous blood glucose monitoring will be performed on three occasions during the study.
Pramlintide will be begun at a single basal rate of 1.5 units/hr. Bolus therapy will be begun thereafter per standard manufacturer protocol. Subjects will be monitored for three months on basal-bolus pramlintide therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 1 diabetes of at least one year duration;
- •Treated with CSII therapy for at least 6 months;
- •Age 18 to 70 years, inclusive;
- •A1C >7.0 and ≤10% as screening;
- •BMI ≤35 kg/m2;
- •Stable insulin dose (±10%) for at least 3 months prior to screening;
- •If female, has a negative urine pregnancy test at screening;
- •If female and of childbearing potential, practicing and willing to continue to using appropriate contraception to ensure that pregnancy does not occur during the study;
- •Able to understand and sign the required study documents and comply with the protocol requirements
排除标准
- •Is poorly compliant with the currently prescribed insulin regimen, as determined by the investigator;
- •Has any significant medical condition, laboratory findings, or medical history that may affect successful completion of the study and/or personal well-being;
- •If female and if of childbearing potential, is pregnant, lactating, or planning to become pregnant;
- •Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months;
- •Has a history of hypoglycemia unawareness;
- •Has a confirmed diagnosis of gastroparesis;
- •Requires the use of drugs that stimulate gastrointestinal motility;
- •Is receiving medications known to interfere with glycemic control (i.e. glucocorticoids);
- •Has been treated with any oral antidiabetic agent or exenatide within 3 months of screening visit;
- •Has been treated with pramlintide within 3 months of screening visit;
- •Has received an investigational drug within 3 month of screening visit;
- •Is currently participating in a clinical trial
研究组 & 干预措施
A
Interventional, continuous pramlintide infusion at 9 micrograms/hr plus 60 microgram meal bolus plus continuous insulin basal-bolus subcutaneous infusion
干预措施: Continuous Pramlintide infusion (Drug)
结局指标
主要结局
Fasting and postprandial pramlintide pharmacokinetics
时间窗: Four months
次要结局
- Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction(four months)
- Hemoglobin A1c(16 weeks)
研究者
David M. Huffman MD
Principal Investigator
University Diabetes & Endocrine Consultants