EUCTR2009-016604-23-IT进行中（未招募）不适用
A multi-center, double-blind, placebo-controlled, randomized study to compare the effect of a subcutaneous canakinumab administration to placebo in patients with Impaired Glucose Tolerance or patients with Type 2 Diabetes treated with differing baseline diabetes therapies - ND
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 232
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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria during the Screening Period: 1. Patients must give written informed consent before any study related procedures are performed. 2. Patient must fulfill all criteria in one of the following groups: a. Impaired Glucose Tolerance (IGT) as defined by WHO criteria confirmed during the Screening Visit. o Morning fasting plasma glucose concentration less than 126 mg/dl (7.0 mmol/l) o Two hour plasma glucose concentration from Oral Glucose Tolerance Test (OGTT) of 75 g oral glucose ingestion greater than 140 mg/dl (7.8 mmol/l), but less than 200 mg/dl (11.1 mmol/l) o Will not be started on an anti-diabetic medicine during the course of screening/run-in or treatment periods b. Documented diagnosis of Type 2 diabetes in stable metformin monotherapy o be on stable metformin monotherapy treatment at a dose at least 1000 mg/day for at least three months at Screening o take metformin as their first and only treatment with anti-diabetes drug therapy (except for short term treatment courses with insulin in connection with hospitalization, etc.) c. Documented diagnosis of Type 2 diabetes in stable treatment with metformin in combination with a sulfonylurea o be on stable metformin and sulfonylurea combination therapy treatment for at least three months at Screening o Metformin dose at least 1000 mg/day at screening o Sulfonylurea dose at least half of the maximally labeled dose for the specific drug o Never have been in more than dual oral treatment for diabetes (except for short term treatment courses with insulin in connection with hospitalization, etc.) d. Documented diagnosis of Type 2 diabetes in stable treatment with metformin, sulfonylurea and thiazolidinedione combination therapy o be on stable metformin and sulfonylurea and thiazolidinedione combination therapy treatment for at least three months at Screening o Metformin dose at least 1000 mg/day at screening o Sulfonylurea dose at least half of the maximally labeled dose for the specific drug o Thiazolidinedione dose at least half of the maximally labeled dose for the specific drug e. Documented diagnosis of Type 2 diabetes in stable treatment with at least two insulin injections (of any type of insulin or insulins) a day with or without metformin o be on stable treatment with at least two injections of insulin with or without metformin for at least three months at Screening o Total daily insulin dose less than 100 U. 3. At the Randomization Visit, patient must still be on the same regimen/dose of antidiabetic medication(s) as at the Screening Visit; does not apply to IGT group. 4. Have an HbA1c between 6.5% and 8%, inclusive, at Screening analyzed by the Central Laboratory; this criterion does not apply to the IGT group 5. Age from 18-74 years, inclusive, and of either sex.
- •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
- •Patients will be excluded if they fulfill any of the following criteria during screening or prior to randomization: 1. Type 1 diabetes, diabetes that is a result of pancreatic injury or other secondary forms of diabetes, e.g. Cushing s syndrome and acromegaly. 2. Any of the following significant laboratory abnormalities: Serum GAD-antibody positivity analyzed by the Central Laboratory. Clinically significant TSH outside of normal range as judged by the Investigator at Screening analyzed by the Central Laboratory. One retest during the screening period may be allowed per Sponsor approval. Renal function indicating high risk metformin use, including serum creatinine concentrations (≥1.5 mg/dL for males, ≥1.4 mg/dL for females) or other evidence of abnormal creatinine clearance. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Screening, confirmed with repeat measure within one week. Total bilirubin >2 times ULN and/or direct bilirubin greater than the ULN at Screening, confirmed by a repeat measurement within one week. 3. History or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as evidenced by any of the following: History of positive PPD skin test result followed by positive chest x-ray/positive QFT-G test and no completion of treatment. A positive PPD skin test followed by a positive chest x-ray or positive QFT(-G) test (with or without positive chest x-ray) during the screening period. History of a positive QFT(-G) test and no completion of treatment. History of a positive AFB sputum sample and no completion of treatment. Requirement for administration of antibiotics against latent tuberculosis (e.g., isoniazide). Courses of antibiotic therapy started prior to entering the study should not be prematurely terminated to allow inclusion into the study. 4. One of the risk factors for TB such as: History of any of the following: residence in a congregate setting (e.g. jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g. injection or non-injection); health-care workers with unprotected exposure to patients who are at high risk of TB or patients with TB disease before the identification and correct airborne precautions of the patient, or Close contact {i.e. share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)} with a person with active pulmonary TB disease. 5. Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven or suspected to be related to immunocompromisation, including patients with evidence of Human Immunodeficiency Virus (HIV) infection. 6. Known presence or suspicion of active or recurrent Hepatitis B and Hepatitis C infections (based on history and/or findings from the Central Lab). 7. Known chronic liver disease of any aetiology. 8. Any surgical or underlying hepatic, hematologic, pulmonary, infectious, autoimmune or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in immunodulatory therapy. 9. Any systemic treatment or local treatment of any immune modulating agent in doses with systemic effects. Topical, inhaled or local steroid use, in doses that are
研究者
相似试验
进行中（未招募）
不适用
Study to assess the safety and efficacy of KRP203 in active subacute cutaneous lupus erythematosus patients, who have shown poor response to standard treatment.Subacute cutaneous lupus erythematosus, in patients who do not respond to first line therapies (i.e. antimalrials)MedDRA version: 14.0Level: HLTClassification code 10025135Term: Lupus erythematosus (incl subtypes)System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2010-019689-10-GRovartis Services AG24
进行中（未招募）
1 期
Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagMedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary arterial hypertensionEUCTR2017-000216-42-PTActelion Pharmaceuticals Ltd100
进行中（未招募）
不适用
A multi-center, double-blind, placebo-controlled, randomized, multiple dose, 2-period cross-over, Phase IIa study to investigate the pharmacodynamics, tolerability and safety, and pharmacokinetics of ACT 129968 in subjects with mild to moderate allergic asthmaAllergic AsthmaEUCTR2008-001209-41-NLActelion Pharmaceuticals Ltd18
进行中（未招募）
不适用
A multi-center, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy and tolerability of KRP203 in patients with active subacute cutaneous lupus erythematosus. - NDactive subacute cutaneous lupus erythematosusMedDRA version: 9.1Level: HLTClassification code 10025135EUCTR2010-019689-10-ITOVARTIS FARMA24
进行中（未招募）
不适用
A multi-center, double-blind, placebo-controlled, parallel-group study to establishproof-of-concept and explore the efficacy of different doses of ACT-129968 in adultpatients with partly controlled asthma. - CONTROAllergic asthmaMedDRA version: 12.1Level: LLTClassification code 10001705Term: Allergic asthmaEUCTR2009-011975-60-BGActelion Pharmaceuticals Ltd.412