Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases (MAG1C)
Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases: A Randomised, Placebo-controlled Trial
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.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Capital Region
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Gentofte、Capital Region、丹麦、2820
- Steno Diabetes Center Copenhagen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention
Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
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其他名称：
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安慰剂比较：Placebo
Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in HbA1c
大体时间：6 months
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Change in HbA1c from baseline to end of study (time 6 months)
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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adverse events (including hypoglycaemic episodes)
大体时间：6 months
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6 months
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changes in insulin dosage
大体时间：6 months
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6 months
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changes in body weight
大体时间：6 months
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6 months
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changes in BMI
大体时间：6 months
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6 months
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changes in body composition
大体时间：6 months
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DXA scan measuring bonemineral density
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6 months
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changes in body composition
大体时间：6 months
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DXA scan measuring lean mass
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6 months
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changes in body composition
大体时间：6 months
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DXA scan measuring fat mass
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6 months
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changes in fasting plasma glucose
大体时间：6 months
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6 months
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changes in post prandial plasma glucose
大体时间：6 months
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6 months
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changes in fasting plasma levels of C-peptide
大体时间：6 months
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6 months
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Quality of life self reported
大体时间：6 months
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Quality of Life Questionaire
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6 months
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Treatment satisfaction
大体时间：6 months
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Diabetes treatment satisfactory questionnaire status version
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6 months
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Treatment satisfaction
大体时间：6 months
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Diabetes treatment satisfactory questionnaire change version
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6 months
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dietary patterns
大体时间：6 months
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Food frequency questionaire three times during the intervention
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6 months
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HDL (High Density Lipoprotein)
大体时间：6 months
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6 months
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LDL (Low Density Lipoprotein)
大体时间：6 months
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6 months
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VLDL (Very Low Density Lipoprotein)
大体时间：6 months
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6 months
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总胆固醇
大体时间：6个月
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6个月
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triglycerides
大体时间：6 months
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6 months
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proBNP (Pro-Brain Natriuretic Peptide)
大体时间：6 months
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6 months
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hsCRP (High-Sensitivity C-Reactive Protein)
大体时间：6 months
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6 months
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合作者和调查者
出版物和有用的链接
一般刊物
- Johansen NJ, Dejgaard TF, Lund A, Vilsboll T, Andersen HU, Knop FK. Protocol for Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetes Cases (The MAG1C trial): a randomised, double-blinded, placebo-controlled trial. BMJ Open. 2018 Jun 27;8(6):e021861. doi: 10.1136/bmjopen-2018-021861.
- Johansen NJ, Dejgaard TF, Lund A, Schluntz C, Frandsen CS, Forman JL, Wewer Albrechtsen NJ, Holst JJ, Pedersen-Bjergaard U, Madsbad S, Vilsboll T, Andersen HU, Knop FK. Efficacy and safety of meal-time administration of short-acting exenatide for glycaemic control in type 1 diabetes (MAG1C): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2020 Apr;8(4):313-324. doi: 10.1016/S2213-8587(20)30030-9. Epub 2020 Mar 2.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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