EUCTR2007-003956-12-FI进行中（未招募）不适用
Investigation of safety and efficacy of five doses of NNC 0113-0217 versus placebo and open-label liraglutide, as add on therapy, in subjects diagnosed with type 2 diabetes currently treated with metformin or controlled with diet and exerciseA 12 week multi-centre, multi national, double-blind, placebo-controlled, randomised, nine armed parallel group, dose finding trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 517
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
- •1.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •2.Men and women-not-of-childbearing-potential diagnosed with type 2 diabetes for at least three months prior to trial
- •3.Men and women-not-of-childbearing-potential treated with diet and exercise alone, or who have been on stable doses of metformin (= 1500 mg) for at least three months prior to trial
- •The definition of women-not-of-childbearing-potential is: females who have been permanently sterilised (i.e. hysterectomy or bilateral oophorectomy), or who are postmenopausal (i.e. at least 6 months of spontaneous amenorrhoea with serum follicle stimulating hormone (FSH) >40 mU/mL.)
- •Male patients who are sexually active and have partners who are or could be pregnant are willing and required to use a barrier method of contraception (e.g. condom) for the duration of the study and for 90 days following the last dose of study medication.
- •4.HbA1c: 7.0-10.0% (both inclusive)
- •5.Age =18 years, (as allowed according to local guidelines for metformin)
- •6.Body weight: 60.0 kg < body weight < 110.0 kg
- •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
- •1. Treatment with insulin, GLP-1 receptor agonists (including liraglutide), DPP-4 inhibitors, sulphonylurea, thiazolidinediones or Alpha-GIs within the last three months prior to the trial (except for short-term treatment with insulin in connection with an intercurrent illness at the discretion of the Investigator)
- •2. Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
- •3. Subjects known to be Hepatitis B antigen or Hepatitis C antibody positive
- •4. Impaired renal function defined as serum-creatinine = 135 µmol/L (=1.53 mg/dL) for males and = 120 µmol/L (= 1.23 mg/dL) for females (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
- •5. Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
- •6. Clinically significant active cardiovascular disease including history of myocardial infarction within the past six months and/or heart failure (New York Heart Association (NYHA) class III and IV ) at the discretion of the Investigator.
- •7. Uncontrolled treated/untreated hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure =100 mmHg)
- •8. Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer)
- •9. Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator.
- •10. Known or suspected allergy to trial product(s) or related products
- •11. Present or planned use of any drug (except for metformin), which in the Investigator’s opinion could interfere with the glucose levels (e.g. systemic cortisteroids)
- •12. The receipt of any investigational drug within three months prior to screening into this trial
- •13. Previous participation in the randomised phase of this trial. Re-screening is allowed once within the limits of the recruitment period.
- •14. Known or suspected abuse of alcohol or narcotics
- •15. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
研究者
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