Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 34
- 主要终点
- HbA1c
研究概览
简要总结
Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.
详细描述
Diabetes mellitus may be present in patients with cystic fibrosis (mucoviscidosis) starting in the second decade of life. The prevalence increases rapidly with increasing age. As life-expectancy increases in CF, CF-related diabetes will be diagnosed more frequently in the future. Negative consequences of secondary diabetes in cystic fibrosis include:
- Catabolic metabolism
- Weight loss
- More frequent / more severe infections
- Deterioration of pulmonary function
- Reduced life-expectancy
- Diabetic micro vascular complications (retinopathy, nephropathy, neuropathy)
Up to date, no data are available to answer the question, whether secondary diabetes in CF should always be treated by insulin therapy. Several centres report the successful management of CF-related diabetes using oral anti-diabetic drugs at least for some years. Oral therapies would be less invasive for a patient group which is highly traumatised by a very demanding therapy (multiple drugs including antibiotics, pancreas enzymes, bronchodilators, mucolysis, in addition to physiotherapy, regular inpatient iv-antibiotic therapy etc, finally lung transplants in a subgroup of patients).
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
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for the Screening:
- •Diagnosed cystic fibrosis
- •Age 10 years and older
- •Inclusion Criteria for the therapeutic part of the study:
- •Newly diagnosed Diabetes mellitus in the screening
排除标准
- •Exclusion Criteria for Screening:
- •Diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25)
- •Already treated Diabetes mellitus by oral antidiabetic medication or insulin
- •Exclusion Criteria for the therapeutic part of the study:
- •Systemic steroid therapy during the last 3 months
- •Transplantation (status post TX or on the waiting list for TX)
- •Beginning pulmonary insufficiency, FEV1 < 35% at pulmonary function test in stable condition
- •Pregnancy
- •Already diagnosed and treated diabetes mellitus
- •Patients with diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25) with or without diabetic coma
- •Severe liver insufficiency (chronic hepatitis B, AST or ALT twice the upper limit of normal, Quick's value < 70% which is a contraindication to use Repaglinide)
- •Treatment with an indispensable important drug which contraindicates Repaglinide
- •PEG/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study
- •CF-patients with type 1 diabetes
- •Not patient's consent to randomisation and therapeutic trial
- •Participation on other medical trial
研究组 & 干预措施
1
Repaglinide; oral
干预措施: Repaglinide (Drug)
2
short-acting Insulin (Actrapid)
干预措施: short-acting Insulin (Actrapid) (Drug)
结局指标
主要结局
HbA1c
时间窗: 2 years
次要结局
未报告次要终点