Effects of Pramlintide in Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- HbA1c Value After 28 Days
研究概览
简要总结
The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes.
This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).
详细描述
Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.Other inclusion factors are:
- HbA1c level between 7.5 and 10% inclusive
- Currently using carbohydrate to insulin ratio
- Acceptable form of birth control
Exclusion factors:
- Oral hyperglycemic agents or medications which might affect blood sugar levels
- Recurrent severe hypoglycemia requiring assistance in previous 6 months
- Diagnosis of gastroparesis and/or require use of drugs that stimulate gastrointestinal motility
- Previous use of pramlintide
The study consists of 2 overnight stays at the CTRC where a continuous glucose monitoring system will be worn for twenty-four hours. Blood will be drawn 15 minutes prior to start of each meal and for three hours following each meal. Meals will be controlled for carbohydrate, fat and protein content. Meals will be identical at each CTRC visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 13 and 17 years of age, inclusive
- •Diagnosed with type 1 diabetes for > 1 year
- •Hemoglobin A1c between 7.5 and 10% inclusive
- •Currently using carbohydrate to insulin ratio
- •Acceptable form of birth control
排除标准
- •Use of oral hyperglycemic agents or medications affecting blood sugar levels
- •Recurrent severe hypoglycemia requiring assistance in past 6 months
- •History of hypoglycemia unawareness
- •History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility
- •Previous use of pramlintide
研究组 & 干预措施
1 Symlin
Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
干预措施: pramlintide (Drug)
结局指标
主要结局
HbA1c Value After 28 Days
时间窗: 28
HbA1c values 28 days after randomization
次要结局
- Weight Change After 28 Days Intervention Period(28 days)