NCT02351232已完成2 期
The Lira Pump Trial. The Effects of Liraglutide in Patients With Insulin Pump Treated Type 1 Diabetes: A Randomized Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
A randomized placebo-controlled clinical trial investigating the effects of Liraglutide as an add-on to intensive insulin therapy in overweight insulin pump treated type 1 diabetes patients in suboptimal glycemic control.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes ≥ 1 year
- •BMI > 25 kg/m2
- •Insulin pump ≥ 1 year
- •HbA1c > 58 mmol/mol
- •Use of carbohydrate counting and the insulin pump bolus calculator
排除标准
- •Gastroparesis
- •Impaired renal function (eGFR < 60 ml/min/1.73m2)
- •Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- •Acute or chronic pancreatitis or history of chronic pancreatitis or idiopathic acute pancreatitis
- •Inflammatory bowel disease
- •History of cancer (except basal cell skin cancer) which in the investigators opinion could interfere with the results of the trial, or cancer during the past 5 years
- •Thyroid adenoma
- •Subjects with personal or family history of MTC or MEN2
- •Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- •Known or suspected alcohol or drug abuse
- •Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
- •Simultaneous participation in any other clinical intervention trial
- •Known or suspected hypersensitivity to Liraglutide
- •Inability to understand the patient information and to give informed consent
- •Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
- •Any Cardiac disorder which in the investigators opinion could interfere with the safety and results of the trial.
研究组 & 干预措施
Intervention
Experimental
Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months
干预措施: Liraglutide (Drug)
Placebo
Placebo Comparator
Placebo; daily subcutaneous injection; 1.8 mg; 6 months
干预措施: Placebo (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
- Change in blood pressure(6 months)
- Change in weight(6 months)
- Change in body composition as measured by DXA-scan(6 months)
- Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire(6 months)
- Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale(6 months)
- Change in insulin pump settings(6 months)
- Change in glucose variability as measured by continuous glucose monitoring(6 months)
- Change in kidney function as measured by urine albumine/creatinine ratio(6 months)
- Number of daily blood glucose measurements(6 months)
- Change in diet as measured by retrospective food recording(6 months)
- Frequency of hypoglycemia (patient reported number of episodes with blood glucose <3.9 mmol/l)(6 months)
- Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides)(6 months)
研究者
Signe Schmidt
MD, PhD
Hvidovre University Hospital
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Liraglutide in Newly Onset Type 1 Diabetes.Diabetes Mellitus, Type 1NCT01879917Hvidovre University Hospital65
已完成
不适用
Treatment of Diabetic Neuropathy With LiraglutideType 1 Diabetes MellitusDiabetes Mellitus, Type 1NCT02138045Aalborg University Hospital39
已完成
4 期
52 Week Trial of Liraglutide in Type 1 DiabetesType 1 DiabetesNCT01787916CHU de Quebec-Universite Laval15
已完成
2 期
Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)ObesityBipolar DisorderNCT03158805Lindner Center of HOPE60
已完成
1 期
The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01536665Novo Nordisk A/S45