EUCTR2014-001381-96-AT进行中（未招募）1 期
A randomized, double blind, two-period cross-over trial investigating the effect of liraglutide as add on to intensive insulin treatment on the endogenous glucose production in subjects with C-peptide positive type 1 diabetes mellitus - LG_T1_EGP
Medizinische Universität Graz / Endokrinologie und Stoffwechsel0 个研究点开始时间: 2014年5月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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 procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •2.Type 1 diabetes mellitus as diagnosed (including I - III):
- •I.history of type 1 diabetes mellitus manifestation with acute hyperglycaemia and ketonuria
- •II.positive results for at least one of four islet antibodies (glutamic acid decarboxy-lase, protein tyrosine phosphatase, zinc transporter 8, or islet cell antibodies)
- •III.residual basal fasting C-peptide of = 0.1 nmol/L
- •3.Male or female, aged 18 – 64 years (both inclusive)
- •4.Body mass index (BMI) 19.0 - 28.0 kg/m2 (both inclusive)
- •5.HbA1c = 80 mmol/mol (= 9.5%)
- •6.Treated with daily insulin injections or continuous s.c. insulin infusion (CSII) = 1 months. Stable insulin dose as judged by the investigator
- •7.Able and willing to perform self-monitoring of PG according to the protocol, to keep a diabetes diary and willing to use liraglutide pen-device
- •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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known or suspected hypersensitivity to trial product(s) or related products
- •2.Use of liraglutide or exenatide within 3 months before screening
- •3.Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 3 months)
- •4.Severe hypoglycaemia within 1 month of screening
- •5.Hypoglycaemia unawareness as judged by the Investigator or hospitalisation for dia-betic ketoacidosis during the previous 2 months
- •6.Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or coagulation screening tests, as judged by the investigator and any of the following laboratory safety results:
- •ASAT, ALAT, lipase, alkaline phosphatase > 2.0 times upper limit of reference range (ULN)
- •Haemoglobin < 8.0 mmol/L (male) or < 6.4 mmol/L (female), total leukocyte count < 3.0 x 109/L, thrombocytes <100 x 109/L
- •Serum creatinine levels = 126 µmol/L (male) or = 111 µmol/L (female)
- •Amylase above normal range
- •7.Screening calcitonin > 50 ng/L
- •8.Family or personal history of multiple endocrine neoplasia type 2 (MEN2), or family history of medullary thyroid cancer (MTC)
- •9.Personal history of non-familial medullary thyroid carcinoma
- •10.History of chronic or idiopathic acute pancreatitis
- •11.Suffer from or history of a life threatening disease (e.g. cancer except basal cell skin cancer or squamous cell skin cancer), or any clinically significant respiratory, meta-bolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the investigator.
- •12.Cardiac problems defined as decompensated heart failure (New York Heart Associa-tion (NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months prior to screening and/or acute myocardial infarction at any time.
- •13.Supine blood pressure at screening (after resting for 5 min) outside the range of 90?140 mmHg for systolic or 50?90 mmHg for diastolic (repeated measurement on a second screening Visit allowed to exclude white-coat hypertension). This exclusion criterion also pertains to subjects being on antihypertensives.
- •14.Clinically significant abnormal ECG at screening, as judged by the investigator.
- •15.Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular auto-nomic neuropathy, as judged by the investigator.
- •16.Any disease or condition that, in the opinion of the investigator, would represent an unacceptable risk for the subject’s safety.
- •17.Subject positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (or diagnosed with active hepatitis according to local practice).
- •18.Positive result of the screening test for HIV-1 antibodies, HIV-2 antibodies and/or HIV-1 antigen according to locally used diagnostic testing.
- •19.History of multiple and/or severe allergies to drugs or foods or a history of severe ana-phylactic reaction.
- •20.Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening.
- •21.Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening.
- •22.Current treatment with systemic (oral or i.v.) corticosteroids, MAO inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Fur-thermore, thyroid hormones are not allowed unless the use of these has been stable during the p
研究者
相似试验
进行中（未招募）
不适用
A double-blind, randomised, two-period crossover study to evaluate the hypnotic effects and safety of sublingual zolpidem for the treatment of insomnia.Primary insomniaMedDRA version: 8.1Level: LLTClassification code 10036701Term: Primary insomniaEUCTR2006-005711-10-BEOrexo AB72
已完成
3 期
Clinical trial on sleep disordersCTRI/2023/02/049470CSIR Indian Institute of Integrative Medicine40
进行中（未招募）
不适用
A double-blind, randomized, 2-way cross-over, phase II, efficacy trial in cancer patients to assess the overall efficacy, patient preference, morphine related side effect profile and safety of the Egalet® controlled release morphine formulation 30-240 mg once daily compared to MST Continus® 15-120 mg twice daily after 2 weeks of treatmentcancer patientsMedDRA version: 8.1Level: LLTClassification code 10058019Term: Cancer painEUCTR2006-006579-19-LTEgalet a/s60
进行中（未招募）
不适用
A randomized, double-blind, two way cross-over, proof of concept study to compare the efficacy, safety, pharmacokinetics and pharmacodynamics of two-week oral administration of QAV680 versus placebo, with an extended open-label inhaled corticosteroid period, in steroid-free, mild to moderate persistent asthma patientsEUCTR2008-005168-15-DEovartis Pharma Services AG50
已完成
2 期
Safety , Pharmacokinetics and efficacy of QAV680 in asthma patientsCTRI/2009/091/000282ovartis Healthcare Pvt Ltd50