EUCTR2014-001215-39-FI进行中（未招募）1 期
A randomised, double-blind, double-dummy, placebo-controlled, parallel-group multi-centre clinical proof-of-principle trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of NNC0114-0006 and liraglutide on preservation of beta-cell function
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 304
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •2. T1DM (as diagnosed clinically*) = 20 weeks prior to screening
- •3. Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form
- •4. Non-fasting peak C-peptide =0.2 nmol/l during MMTT at Visit 2
- •5. BMI =18.5 kg/m^2
- •6. Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening
- •7. Insulin dependence unless in temporary spontaneous remission (honeymoon period).
- •*The clinical diagnosis of T1DM is defined as by the following two paragraphs:
- •1. One or more of the following:
- •- HbA1c = 6.5% or
- •- fasting plasma glucose = 7.0 mmol/l (126 mg/dl) or
- •- a 2 hour plasma glucose = 11.1 mmol/l (200 mg/dl) during an oral glucose tolerance test
- •with a glucose load of 75 grams anhydrous glucose in water or
- •- classical symptoms of hyperglycaemia and a random plasma glucose = 11.1 mmol/l (200
- •In the absence of unequivocal hyperglycaemia, results should be confirmed by repeat testing.
- •2. In order to:
- •- ensure that the aetiology is autoimmune, the clinical diagnosis needs to be confirmed by the presence of islet-specific auto-antibodies at screening
- •- exclude type 2 diabetes mellitus (T2DM) and latent autoimmune diabetes of adults (LADA) the subjects should be without severe insulin resistance (i.e. total daily insulin dose larger than 1 U/kg per day at screening).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 304
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Daily insulin usage > 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII)
- •2. History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis)
- •3. History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy
- •4. Vaccination within 4 weeks before randomisation, Visit 3 (V3)
- •5. Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1)
- •6. History of pancreatitis (acute or chronic)
- •7. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
- •8. Any past or current diagnosis of malignant neoplasms
- •9. Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo
研究者
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