Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases: A Randomised, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of <7.0% as the treatment goal.
Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain, and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance.
The abovementioned problems associated with insulin treatment in T1D can also be seen in insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in reducing the weight gain and insulin dose in insulin-treated patients with T2D without exacerbating the risk of hypoglycaemia.
Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin therapy for patients with T1D.
The investigators hypothesise that the add-on of exenatide to insulin therapy in patients with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve glycaemic control without increasing the risk of hypoglycaemia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1D according to WHO criteria with duration of ≥1 year
- •Age ≥18 years
- •BMI >22.0 kg/m2
- •HbA1c >7.5% and <10.0% at visit 0 (screening)
- •Able to count carbohydrates
排除标准
- •Insulin pump treatment
- •Hypoglycaemia unawareness (inability to register low blood glucose)
- •Diabetic gastroparesis
- •Compromised kidney function (eGFR <60 ml/min/1.73m2, dialysis or kidney transplantation)
- •Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- •History of acute and/or chronic pancreatitis
- •Subjects with personal or family history of medullary carcinoma or MEN syndrome
- •Inflammatory bowel disease
- •Cancer unless in complete remission for >5 years
- •Proliferative retinopathy
- •Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- •Alcohol/drug abuse
- •Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- •Pregnant or nursing women
- •Known or suspected hypersensitivity to trial product or related products
- •Receipt of an investigational drug within 30 days prior to visit 0
- •Simultaneous participation in any other clinical intervention trial
研究组 & 干预措施
Intervention
Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
干预措施: Exenatide (Drug)
Placebo
Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
干预措施: Placebos (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: 6 months
Change in HbA1c from baseline to end of study (time 6 months)
次要结局
- changes in BMI(6 months)
- changes in fasting plasma levels of C-peptide(6 months)
- dietary patterns(6 months)
- VLDL (Very Low Density Lipoprotein)(6 months)
- proBNP (Pro-Brain Natriuretic Peptide)(6 months)
- changes in fasting plasma glucose(6 months)
- HDL (High Density Lipoprotein)(6 months)
- triglycerides(6 months)
- hsCRP (High-Sensitivity C-Reactive Protein)(6 months)
- adverse events (including hypoglycaemic episodes)(6 months)
- changes in insulin dosage(6 months)
- changes in post prandial plasma glucose(6 months)
- Treatment satisfaction(6 months)
- total cholesterol(6 months)
- changes in body weight(6 months)
- changes in body composition(6 months)
- Quality of life self reported(6 months)
- LDL (Low Density Lipoprotein)(6 months)
研究者
Filip Krag Knop
Professor, MD, PhD
University Hospital, Gentofte, Copenhagen