Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in gastric emptying rate
研究概览
简要总结
The purpose of this study is to:
Part 1:
To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.
Part 2:
To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.
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
- •Age: 18-70 years
- •BMI: 18-28
- •HbA1c ≥ 8 %
- •No residual β-cell function (glucagon test with c-peptide < 60 pM)
- •Caucasian
- •Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive).
- •Remission phase must be completed
- •Female participants must use adequate contraception
- •Informed consent
排除标准
- •Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy, macroalbuminuria.
- •Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH).
- •Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l
- •Pregnancy or lactation
- •Use of antiepileptic medication
- •Use of beta blockers
- •Previously apoplexy cerebri.
- •Any use of benzodiazepine within the last month
- •Any use of neuroleptic drugs within the last six months
- •Self-perceived hearing loss
- •Alcohol or drug abuse
- •Allergy to the medication or placebo.
- •Treatment with any medication affecting glucose metabolism.
- •Any disorder which in the investigators opinion could interfere with the safety and results of the trial
研究组 & 干预措施
Placebo + Insulin + Study 2
Study 2: Cognitive performance test
干预措施: Liraglutide (Drug)
Liraglutide + Insulin + Study 2
Study 2: Cognitive performance test
干预措施: Placebo (Drug)
Liraglutide + Insulin + Study 1
Study 1: Gastric emptying test
干预措施: Liraglutide (Drug)
Placebo + Insulin + Study 1
Study 1: Gastric emptying test
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in gastric emptying rate
时间窗: week 0, week 12
Change from baseline in HbA1c (glycosylated haemoglobin)
时间窗: Week 0, week 12
Changes from baseline in EEG and cognitive performances
时间窗: week 0, week 12
次要结局
- Change from baseline in glycemic control (CGM)(week 0, week 12)
- Changes from baseline in the counterregulatory hormone responses during hypoglycemia(week 0, week 12)
- Change from baseline in corrected QTc-interval (QTc) during hypoglycemia(week 0, week 12)
- Change from baseline in total daily insulin dose(week 0, week 12)
- Change from baseline in body weight(week 0, week 12)
- Change from baseline in auditory evoked potentials (AEP) during hypoglycemia(week 0, week 12)
- Change from baseline in hypoglycemic symptom score(week 0, week 12)
研究者
Christan SS Frandsen, MD
MD
Hvidovre University Hospital