Phase 4 Crossover Study Comparing the Effect of Insulin Glulisine to Insulin Aspart on Breakfast Post Prandial Blood Glucose Levels in Prepubertal Children With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Difference in the Two Hour and Four Hour Post Prandial Blood Glucose Levels Following Administration of Insulin Glulisine Versus Insulin Aspart at the End of the Twenty Study Days
研究概览
简要总结
To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.
详细描述
This is a treatment, open label, crossover study comparing two and four hour breakfast post prandial blood glucose levels after receiving a dose of insulin glulisine or insulin aspart administered subcutaneously and consuming the breakfast meal from a prescribed menu containing 45, 60 or 75 grams of carbohydrate. Each subject will receive insulin glulisine for ten days and insulin aspart for ten days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current patient in the Helen DeVos Children's Hospital Diabetes Clinic;
- •ages 4-11 years;
- •prepubertal (Tanner Stage I);
- •diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or presenting at time of diagnosis with positive serum or urine ketones and requiring insulin since diagnosis;
- •at least six months from date of diagnosis of type 1 diabetes mellitus;
- •TSH within reference range and negative transglutaminase IgA antibodies within nine months of study start;
- •HbA1C between 6.9 and 10% within 30 days of study start; parent or guardian able and willing to provide written informed consent prior to enrollment;
- •at time of study start, current insulin regimen includes multiple daily injections with insulin glargine as the basal insulin and insulin aspart or insulin lispro as the pre-meal rapid acting insulin
排除标准
- •pubertal (Tanner stage 2 or greater);
- •concurrent Addison's disease, celiac disease or untreated hypothyroidism; - receiving oral, injectable or inhaled steroids or immunosuppressant medications;
- •receiving stimulants for treatment of attention deficit disorder or attention deficit hyperactivity disorder;
- •intercurrent illnesses such as a fever > 101 degrees F, infection, or gastroenteritis;
- •use of any medication to treat diabetes other than those listed under in inclusion criteria;
- •potential for lack of compliance or any other issue which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
研究组 & 干预措施
insulin glulisine
干预措施: insulin glulisine (Drug)
insulin aspart
干预措施: insulin aspart (Drug)
结局指标
主要结局
Difference in the Two Hour and Four Hour Post Prandial Blood Glucose Levels Following Administration of Insulin Glulisine Versus Insulin Aspart at the End of the Twenty Study Days
时间窗: measured daily at baseline, 2 and 4 hours post prandial for 20 days
Compare average blood glucose at 2 and 4 hours post prandial minus blood glucose at baseline (prior to eating)
次要结局
- Occurrence of Hypoglycemia;(measured daily at 2 and 4 hours postprandial for 20 days)