Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean weekly blood glucose concentrations.
研究概览
简要总结
This is the first prospective randomized double-blind placebo-controlled study to investigate the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of the drug are consistent with a sustained duration of action. The current gold standard for management of type 1 diabetes is based on insulin replacement with novel analogs with specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump therapy). No other adjuvant therapy has demonstrated sustained benefit in this population. This study will also investigate the effect of liraglutide on suppression of glucagon secretion during meal challenges. This is of particular importance since, in the absence of insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will allow us to determine the rapidity, consistency, and sustainability of any response to liraglutide.
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
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Females and males with Type 1 diabetes as ascertained by islet autoantibodies (GAD-65 and/or islet cell antibodies)
- •Age 15-30 years - This age group is being chosen as most will have completed puberty with the accompanying physiologic phase of increased insulin resistance. In addition, this age group shows increased self-management capabilities. Extending the age up to 30 years will allow us to include young adults, since type 1 diabetes is frequently diagnosed in the late teen and early adult years. This study is not powered to detect differences in liraglutide efficacy in different age group but it may provide insight into the effectiveness in the teenage population, in whom optimal glycemic control is often a challenge.
- •Type 1 diabetes duration greater than 1 year to ensure that a majority of subjects are beyond the partial remission period.
- •Fasting C-peptide level ≤ 0.3 ng/ml.
- •HbA1c level equal or less than 9%
- •Insulin delivery by CSII - the choice is made to facilitate adherence to study drug and also to enable us have a homogeneous group to analyze without having to analyze the data for the covariants of CSII vs. multiple daily injection therapy.
- •Subjects willing to wear a CGM sensor and perform home blood glucose monitoring four times daily and with symptoms of hypoglycemia.
- •Subjects well-versed in carbohydrate counting.
- •BMI < 95th% for age and gender.
排除标准
- •EXCLUSION CRITERIA:
- •Previous exposure to liraglutide
- •History of abdominal surgery
- •History of gastroparesis or gastrointestinal reflux disease;
- •History of acute or chronic pancreatitis
- •Cirrhosis or hepatic disease defined as transaminases levels > 3 times normal
- •Impaired renal function defined as serum creatinine >1.
- •HIV or Hepatitis C positive status
- •Pregnant/breastfeeding females
- •Individuals with steroid-induced or cystic fibrosis related diabetes
- •Diabetic Ketoacidosis within 6 months of the study
- •History of severe hypoglycemia (seizure, loss of consciousness) within 6 months of the study
- •History of medullary thyroid cancer or MEN2 syndrome
- •Any other life-threatening cardiac or non-cardiac disease
- •Participation in a concurrent clinical trial or participation in a trial within 30 days preceding the study period.
- •Unable to give informed consent/assent.
- •Adolescents and adults who are considered underweight based on body mass index (BMI):
- •For adolescents: BMI less than the 5th percentile
- •For adults: BMI below 18.5
研究组 & 干预措施
Liraglutide 0.6mg
Daily Injection
干预措施: Liraglutide (Drug)
Placebo
Daily Injection
干预措施: Placebo (Drug)
结局指标
主要结局
Mean weekly blood glucose concentrations.
时间窗: 3 Months
The primary endpoint of the study is to detect a difference between Liraglutide and placebo groups in the change from baseline in mean weekly blood glucose concentrations after 12 weeks of treatment.
次要结局
- HbA1c(3 Months)
研究者
Paresh Dandona
Distinguished Professor of Medicine
Kaleida Health