Treatment of Hypoglycemia With Glucagon Among Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximum plasma glucose response
研究概览
简要总结
Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin and are advised to aim for near-normalization of blood glucose levels through intensive insulin therapy. We propose a new approach for achieving treatment goals in T1D: the combined use of insulin and glucagon, i.e. dual-hormone treatment.Only recently the prospect of treating patients with soluble glucagon has arisen and thus studies of low dose glucagon treatment of mild hypoglycemia are needed to determine whether there is clinical rationale for dual-hormone treatment of T1D.
Aim: The purpose of this clinical study is to investigate the glycemic response to subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with insulin pump. Different glucagon doses are applied to determine the most appropriate dose for future dual-hormone treatment of T1D.
Methods: A clinical, randomized, single blinded, crossover study will be conducted. Eight T1D patients treated with insulin pump are studied on four days. All patients are in good metabolic control (HbA1c < 7.5%), C-peptide negative and with hypoglycemia awareness. On each study day, hypoglycemia is induced with subcutaneously insulin and afterward treated with a single subcutaneous dose of glucagon. The study procedures are identical on all days except from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug, day 4: 300 ug). All patients are blinded for the glucagon dose and carry out the four days in random order.
Endpoints: The present study focuses primarily on the dose related plasma glucose response of glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary the glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and triglycerides.
The study will be conducted from august 2014.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-65 years
- •Diagnosed with type 1 diabetes > 3 years
- •HbA1c < 58 mmol/mol
- •No appearance of autonome neuropathy
- •Body mass index (BMI) between 20-25 kg/m2
- •Remained hypoglycemic awareness
- •Insulin pump treatment > 1 year
排除标准
- •Allergic to glucagon or lactose
- •Pregnancy, breast-feeding, intention of becoming pregnant, or not using adequate contraception
- •Any disease or condition which would interfere with the subject's safety
- •Use of a medication that significantly impacts glucose metabolism
研究组 & 干预措施
Placebo
Isotonic Saline
干预措施: Isotonic saline solution (Other)
Glucagon 0.1 mg
GlucaGen(r) 0.1 mg administration
干预措施: Glucagon (Drug)
Glucagon 0.2 mg
GlucaGen(r) 0.2 mg administration
干预措施: Glucagon (Drug)
Glucagon 0.3 mg
GlucaGen(r) 0.3 mg administration
干预措施: Glucagon (Drug)
结局指标
主要结局
Maximum plasma glucose response
时间窗: Plasma glucose measured every five minutes after administration
次要结局
- Duration of hyperglycemic effect of glucagon(Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration)
研究者
Ajenthen Ranjan
MD, PhD student
Hvidovre University Hospital