EUCTR2008-007012-15-DE进行中（未招募）不适用
A Two-Stage Randomized Placebo-controlled Ascending Dose Phase I/ IIa Study to Evaluate Safety, Tolerability, Pharmacodynamic Effects and Preliminary Efficacy of an Anti-Interleukin 1 beta Vaccine (CYT013-IL1bQb) in Patients with Type 2 Diabetes Mellitus.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 122
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
- 性别
- All
入选标准
- •Diagnosis of type 2 diabetes mellitus, according to the American Diabetes Association diagnostic criteria, = 3 months at time of randomization
- •Stage I: HbA1c in the range of 6.5 - 9.5% (inclusive) at screening/ Stage II: HbA1c in the range of 7.0 – 9.5 % (inclusive)
- •= 18 < 70 years of age at the time of randomization
- •Fasting plasma glucose < 13.4 mmol/L (< 240 mg/dL) at screening
- •Male patients or female patients without childbearing potential. Postmenopausal (at least one year without menstrual period, in case of doubts serum FSH should be determined and must be >30 U/L) or surgically sterilized (documentation required).
- •BMI = 23 kg/m2 and < 40 kg/m2 at screening, and, per patient self-report, following their regular weight maintenance or reduction diet for the management of diabetes for at least 4 weeks prior to randomization
- •Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 4 weeks prior to randomization
- •Subject is able and willing to comply with the study's visit requirements
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Positive for GAD65 or IA-2 auto-antibodies
- •Symptoms of hyperglycemia (i.e. polyuria and polydypsia) in the opinion of the investigator
- •History of significant weight gain or loss (+/- 5%) during the 4 weeks before randomization
- •Fasting C-peptide level < 400 pmol/L at screening
- •Change in the medicamentous treatment of elevated blood pressure, diabetes mellitus or dyslipidemia within 4 weeks prior to the randomization
- •Use of any weight loss medication (over the counter prescription) or initiation of a prescribed weight management or exercise program within 4 weeks before randomization
- •Uncontrolled arterial hypertension defined as diastolic pressure >95 mmHg and/or systolic >170 mmHg
- •Evidence of active infection, CRP > 30 mg/L, history of recent infection or of chronic infection requiring treatment with anti-infectives, hospitalization or therapy with antibiotics within 4 weeks prior to randomization
- •History of tuberculosis or tuberculosis exposure; positive test result in a tuberculosis- specific Interferon gamma release assay at screening
- •Active leg or foot ulcer
- •Persistent asthma or COPD treated with inhalative corticosteroids
- •Known proliferative retinopathy or macular edema
- •White blood cell (leucocytes) count at screening < 3.5 x 10^9/L
- •Absolute neutrophils count at screening < 1.5 x 10^9/L
- •Platelets < 150 x 10^9/L at screening
- •Hemoglobin at screening <11.0 g/dL for female and <12.0 g/dL for male
- •Elevated ALT or AST or GGT or ALP at screening (greater than 2.0 x the upper limit of normal)
- •Serum creatinine at screening >107 mcmol/L for female and >115 mcmol/L for male
- •Estimated glomerular filtration rate (eGFR) at screening < 60 mL/min as calculated via the abbreviated MDRD equation (Modification of Diet in Renal Disease study group)
- •U-ACR (albumin to creatinine ratio in spot urine) > 50 mg/g creatinine
- •Malignancy (present or in anamnesis), with the following exceptions: non-invasive basal cell carcinoma (basaliom) of the skin in anamnesis or carcinoma in situ of cervix uteri in anamnesis
- •Current systemic anti-inflammatory therapy other than aspirin = 100 mg/day or immunosuppressive treatment, in particular oral corticosteroids
- •Receipt of any biologic or immunosuppressive therapy (experimental or commercial), including anakinra (Kineret®), IL-1 beta blocking monoclonal antibodies, soluble IL-1 receptor or any tumor necrosis factor (TNF) blocking agents (eg, etanercept and infliximab), within 3 months of randomization
- •Antidiabetic medication other than metformin, sulfonylurea
- •Planned prophylactic immunization with live vaccines 3 months prior to screening or during the study (including Follow Up)
- •Planned active immunization with other (than live vaccines) prophylactic vaccines within 2 weeks before or 2 weeks after any application of study medication
- •Use of an investigational medicinal product within 30 days before enrolment, or planned use during the whole study period
- •Known autoimmune disease
- •Severe allergy
- •Pregnancy or breastfeeding
- •Women of childbearing age that are not surgically sterilized
- •Patients with a history or current positive test for HIV infection, AIDS, or other immunosuppressive disorders; hepatitis B or C
- •Presence of suspicious lymphadenopathy or splenomegaly on physical examination
- •Drug or alcohol abuse within the past 2 years before screening
- •Presence or history of relevant cardiovascular disease (myocardial infarction
- •<6 months before r
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